Sleep DisordersPhase 2NCT01122849

Exploratory Subjective Sleep Study of a Prototype Nasal Dilator

A Phase 2 study testing Prototype Nasal Dilator and Marketed Nasal Strip in people with Sleep Disorders and Congestion, Nasal, run by GlaxoSmithKline at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this exploratory study is to evaluate the subjective measures of congestion and sleep quality in subjects who suffer from chronic nasal congestion and report trouble with their sleep. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Sleep Disorders, Congestion, Nasal
What is being tested?: Prototype Nasal Dilator and Marketed Nasal Strip
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 61 participants
Where: 2 sitesUnited States
Study dates: 1 Oct 2009to 1 Feb 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects with leptorrhine noses
Subjects suffering from chronic nocturnal nasal congestion and report trouble with sleep

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Valley Clinical Research Center
Bethlehem, Pennsylvania, 18020
TKL Research Inc
Paramus, New Jersey, 07652

Other trials in United States

About this study

The purpose of this exploratory study is to evaluate the subjective measures of congestion and sleep quality in subjects who suffer from chronic nasal congestion and report trouble with their sleep.

Conditions: Sleep Disorders, Congestion, Nasal
Being tested: Prototype Nasal Dilator, Marketed Nasal Strip, Placebo Nasal Strip
Keywords: trouble with sleep, night time nasal congestion
Medical subject headings: Sleep Wake Disorders, Nasal Obstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prototype Nasal DilatorDevice
Prototype nasal dilator AB2R11
Marketed Nasal StripDevice
Breathe Right Nasal Strip- Clear small/medium
Placebo Nasal StripDevice
Placebo strip

Study groups in NCT01122849
Study group	Role	What they receive
Prototype Nasal Dilator	Experimental	Prototype Nasal Dilator Receives: Device: Prototype Nasal Dilator
Marketed Nasal Strip	Active comparator	Marketed Nasal Strip Receives: Device: Marketed Nasal Strip
Placebo Nasal Strip	Placebo comparator	Placebo Receives: Device: Placebo Nasal Strip

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Mean Average Score Using Pittsburgh Insomnia Rating Scale (PIRS) in Q1, Q3, Q17 and Q18 at Day 7
The PIRS questionnaire had 3 sections (Section A [Q1 to Q12], Section B [Q13 to 16] and Section C [Q17 to Q20]). The following questions were asked from Section A : 1. One or more awakenings after getting to sleep and 3 Sleep that does not fully refresh you, and Section C: 17 Your sleep quality compared to most people and 18 Your satisfaction with your sleep. Section A question were scored as follows: 0= Not at all bothered, 1= slightly bothered, 2=moderately bothered, and 3= severely bothered. Section B, Q13 and 14 were scored as follows 0= Less than ½ hour, 1= between ½ to 1 hour, 2= between 1 to 3 hours and 3=more than 3 hours or I didn't sleep; Q15 and 16 were scored as 0=more than 7 hours, 1= between 4 to 7 hours, 2= between 2 to 4 hours, and 3=Less than 2 hours or I didn't sleep. Section C questions were scored as follows: 0=Excellent, 1=Good, 2=Fair, and 3=Poor. Lower PIRS score shows better sleep quality.
Measured: At Baseline and Day 7
Change From Baseline in Mean Average Score Using Pittsburgh Insomnia Rating Scale (PIRS) in Q1, Q3, Q17 and Q18 at Day 14
Participant were asked questions related to their sleep using PIRS questionnaire. The PIRS questionnaire had 3 sections. Section A (Q1 to Q12), Section B (Q13 to Q16) and Section C (Q17 to Q20). Section A question were scored as follows: 0= Not at all bothered, 1= slightly bothered, 2=moderately bothered, and 3= severely bothered. Section B questions 13 and 14 were scored as follows 0= Less than ½ hour, 1= between ½ to 1 hour, 2= between 1 to 3 hours and 3=more than 3 hours or I didn't sleep; Questions 15 and 16 were scored as 0=more than 7 hours, 1= between 4 to 7 hours, 2= between 2 to 4 hours, and 3=Less than 2 hours or I didn't sleep. Section C questions were scored as follows: 0=Excellent, 1=Good, 2=Fair, and 3=Poor. Lower PIRS score shows better sleep quality.
Measured: At Baseline and Day 14
Change From Baseline in Mean Average Score of NRQLQ (Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire) for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) on the) at Day 7
Participants scored all the domains of NRQLQ using same 7 points scale where 0=Not troubled and 6=extremely troubled. Sleep problems (difficulty getting sleep, unable to get a good night sleep or wake up during the night, restless [tossing and turning] and having to get up because stuffy nose or to blow nose using the score, scores range: Min-Max [0-24]), Sleep time problems (Nasal congestion or stuffy nose, sinus pressure or pain, runny nose, post-nasal drip [drainage down back of nose/throat], and headache, scores range: 0-30); Symptoms on waking in the morning (Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up, scores range:0-24); practical problems (have to avoid symptom triggers (such as dust, cigarette smoke, strong smells and perfumes, need to rub nose or eyes, and have to take medication, scores range: 0-18). Lower scores indicate improvement in the rhinitis symptoms.
Measured: At Baseline and Day 7
Change From Baseline in Mean Average Score of NRQLQ (Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire) for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) on the) at Day 14
Participants scored all the domains of NRQLQ using same 7 points scale where 0=Not troubled and 6=extremely troubled. Sleep problems (difficulty getting sleep, unable to get a good night sleep or wake up during the night, restless [tossing and turning] and having to get up because stuffy nose or to blow nose using the score, scores range: Min-Max [0-24]), Sleep time problems (Nasal congestion or stuffy nose, sinus pressure or pain, runny nose, post-nasal drip [drainage down back of nose/throat], and headache, scores range: 0-30); Symptoms on waking in the morning (Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up, scores range:0-24); practical problems (have to avoid symptom triggers such as dust, cigarette smoke, strong smells and perfumes, need to rub nose or eyes, and have to take medication, scores range: 0-18). Lower scores indicate improvement in the rhinitis symptoms.
Measured: At Baseline and Day 14
Change From Baseline in Mean Sum of 7 Questions of Congestion Quantifier 7 Questionnaire (CQ7) at Day 7
Participants answered following questions of CQ7 questionnaire: Q1 -How often did you have nasal stuffiness, blockage, or congestion?, Q2- How often did you have sinus pressure or pain in your face?, Q3-How often did you have to breathe through your mouth because you could not breathe through your nose?, Q4-How often did you have difficulty completely clearing your nose even after repeated blowing?, Q5-How often did any of these symptoms affect your ability to work, learn in school, or do the things you need to do?, Q6-How often did you awaken in the morning with nasal stuffiness, blockage, or congestion?, Q7-How often was your sleep affected by your nasal stuffiness, blockage, or congestion?. Their responses were scored using a 5 point scale where 0=none of the time; 1=a little of the time, 2=some of the time, 3=most of the time, 4=all of the time. Lower CQ7 scores reflect better nasal patency.
Measured: At Baseline and Day 7
Change From Baseline in Mean Sum of 7 Questions of Congestion Quantifier 7 Questionnaire (CQ7) at Day 14
Participants answered following questions of CQ7 questionnaire: Q1 -How often did you have nasal stuffiness, blockage, or congestion?, Q2- How often did you have sinus pressure or pain in your face?, Q3-How often did you have to breathe through your mouth because you could not breathe through your nose?, Q4-How often did you have difficulty completely clearing your nose even after repeated blowing?, Q5-How often did any of these symptoms affect your ability to work, learn in school, or do the things you need to do?, Q6-How often did you awaken in the morning with nasal stuffiness, blockage, or congestion?, Q7-How often was your sleep affected by your nasal stuffiness, blockage, or congestion?. Their responses were scored using a 5 point scale where 0=none of the time; 1=a little of the time, 2=some of the time, 3=most of the time, 4=all of the time. Lowe CQ7 scores reflect better nasal patency.
Measured: At Baseline and Day 14
Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Application at Bedtime on Day 7
Participants were asked how easy it was to breathe through their nose before and after strip application at bedtime. The participants scored their responses on 100 point VAS scale where 0 = extremely difficult to breathe and 100 = extremely easy to breathe. These responses were recorded daily.
Measured: Day 7
Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Application at Bedtime on Day 14
Participants were asked how easy it was to breathe through their nose before and after strip application at bedtime. The participants scored their responses on 100 point VAS scale where 0 = extremely difficult to breathe and 100 = extremely easy to breathe. These responses were recorded daily.
Measured: Day 14
Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Removal in Morning on Day 7
Participants were asked how easy it was to breathe through their nose before and after strip removal in morning. The participants scored their responses on 100 point VAS scale where 0 = extremely difficult to breathe and 100 = extremely easy to breathe. These responses were recorded daily.
Measured: Day 7
Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Removal in Morning on Day 14.
Participants were asked how easy it was to breathe through their nose before and after strip removal in morning. The participants scored their responses on 100 point VAS scale where 0=extremely difficult to breathe and 100=extremely easy
Measured: Day 14
Mean Score in Response to Daily Diary Questions (Q2 and Q4) at Bedtime on Day 7
Questions regarding nasal strips were asked to participants and scores were noted on daily basis. Participants were asked how stuffed their nose felt before and after strip application (Q2) and how breathing felt after strip was applied (Q4) at bedtime. For Q2 the participants scored their responses on a scale of 0 to 3 where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms. For Q4, participants scored their responses on a scale of -5 to 5 where -5=much worse, 0=same, and 5=much better (Q4 was asked after strip application only therefore no data for before application is available for Q4.)
Measured: Day 7
Mean Score in Response to Daily Diary Questions (Q2 and Q4) at Bedtime on Day 14
Questions regarding nasal strips were asked to participants and scores were noted on daily basis. Participants were asked how stuffed their nose felt before and after strip application (Q2) and how breathing felt after strip was applied (Q4) at bedtime. For Q2, the participants scored their responses on a scale of 0 to 3 where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms. For Q4, participants scored their responses on a scale of -5 to 5 where -5=much worse, 0=same, and 5=much better (Q4 was asked after strip application only therefore no data for before application is available for question 4.)
Measured: Day 14
Mean Score in Response to Daily Diary Questions (Q2 and Q4) in Morning on Day 7
Questions regarding nasal strips were asked to participants and scores were noted on daily basis. Participants were asked how stuffed their nose felt before and after strip removal (Q2) and how breathing felt after strip was removed (Q4) in morning. For Q2 the participants scored their responses on a scale of 0 to 3 where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms. For Q4, participants scored their responses on a scale of -5 to 5 where -5=much worse, 0=same, and 5=much better. (Q4 was asked after strip removal only therefore no data for before removal is available for question 4.)
Measured: Day 7
Mean Score in Response to Daily Diary Questions (Q2 and Q4) in Morning on Day 14
Questions regarding nasal strips were asked to participants and scores were noted on daily basis. Participants were asked how stuffed their nose felt before and after strip removal (Q2) and how breathing felt after strip was removed (Q4) in morning. For Q2 the participants scored their responses on a scale of 0 to 3 where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms. For Q4, participants scored their responses on a scale of -5 to 5 where -5=much worse, 0=same, and 5=much better (Q4 was asked after strip removal only therefore no data for before removal is available for question 4.)
Measured: Day 14

Secondary outcomes (12)

Summary for Other Questions of PIRS Questionnaire
The following questions were asked from Section A (Q1 to Q12; 2 Not getting enough sleep, 4 Poor alertness during the daytime, 5 Difficulty keeping your thoughts focused, 6 Others noticing you appeared tired or fatigued, 7 too many difficulties to overcome, 8 Bad moods because you had poor sleep, 9 Lack of energy because of poor sleep, 10 Poor sleep that interferes with your relationships, 11 Being unable to sleep, 12 Being able to do only enough to get by, Section B (Q13 to Q16; 13 From the time you tried to go to sleep, How long did it take to fall asleep on most nights, 14 If you woke during the night, how long did it take to fall back to sleep on most nights,15 Not counting times when you were awake in bed, how many hours of actual sleep did you get during the worst night, 16 On how many days did you have trouble coping because of poor sleep and Section C (Q17 to Q20;, 19 The regularity of your sleep, 20 The soundness of your sleep)
Measured: At Day 7 and Day 14
Summary of Other Daily Diary VAS Scale Questions Before and After Strip Application at Bedtime
Participants were asked how easy it was to breathe through their nose before and after strip application at bedtime. The participants scored their responses on VAS scale where 0 = extremely difficult to breathe and 100 = extremely easy to breathe. These responses were recorded daily.
Measured: At Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day 13
Summary of Other Daily Diary VAS Scale Questions Before and After Strip Removal in Morning
Participants were asked how easy it was to breathe through their nose before and after strip removal in morning. The participants scored their responses on VAS scale where 0 = extremely difficult to breathe and 100 = extremely easy to breathe. These responses were recorded daily.
Measured: At Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day 13
Summary of Other Daily Diary VAS Scale Questions Before and After Strip Application at Bedtime
Participants were asked how open their nose feels before and after strip application at bedtime. The participants scored their responses VAS scale where 0 = nose was extremely blocked and 100 = nose was extremely clear. These responses were recorded daily.
Measured: At Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day 13
Summary of Other Daily Diary VAS Scale Questions Before and After Strip Removal in Morning.
Participants were asked how open their nose feels before and after strip removal in morning. The participants scored their responses VAS scale where 0 = nose was extremely blocked and 100 = nose was extremely clear. These responses were recorded daily.
Measured: At Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day 13
Summary of Daily Diary Questions Before and After Strip Application at Bedtime
Participants were asked how stuffed their nose felt before and after strip application at bed time. The participants scored their responses on the scale of 0 to 3 where 0=No symptoms, 1=mild symptoms and 3=severe symptoms. These responses were recorded daily.
Measured: At Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day 13
Summary of Daily Dairy Questions Before and After Strip Removal in Morning
Participants were asked how stuffed their nose felt before and after strip removal in morning. The participants scored their responses on the scale of 0 to 3 where 0=No symptoms, 1=mild symptoms and 3=severe symptoms. These responses were recorded daily.
Measured: At Day 1, Day 2, day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day 13
Summary of Daily Diary Questions at Bed Time (After Strip Application) and in Morning (After Strip Removal).
Participants were asked how breathing felt after nasal strip was applied at bed time and removed in morning. The participants scored their responses on the scale of -5 to 5 where -5 = much worse, 0 = same and 5= much better. These responses were recorded daily.
Measured: At Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day13
Change From Baseline in Mean Average Score of NRQLQ for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) on the) at Day 7 and Day 14 in Participants With the Risk of Sleep Apnea.
Participants scored all the domains of NRQLQ using same 7 points scale where 0=Not troubled and 6=extremely troubled. Sleep problems (difficulty getting sleep, unable to get a good night sleep or wake up during the night, restless [tossing and turning] and having to get up because stuffy nose or to blow nose using the score, scores range: Min-Max [0-24]), Sleep time problems (Nasal congestion or stuffy nose, sinus pressure or pain, runny nose, post-nasal drip [drainage down back of nose/throat], and headache, scores range: 0-30); Symptoms on waking in the morning (Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up, scores range:0-24); practical problems (have to avoid symptom triggers such as dust, cigarette smoke, strong smells and perfumes, need to rub nose or eyes, and have to take medication, scores range: 0-18). Lower scores indicate improvement in the rhinitis symptoms.
Measured: At Day 7 and at Day 14
Number of Participants Showing Improvement for Sleep Problems and Symptoms on Waking in the Morning Domain of the NRQLQ
Participants scored all two domains of NRQLQ using same 7 points scale: 0=Not troubled, 1=Hardly troubled, 3=moderately troubled, 4=quite a bit troubled, 5=very troubled, 6=extremely troubled. Domains were Sleep problems (difficulty getting sleep, unable to get a good night sleep or wake up during the night, restless [tossing and turning] and having to get up because stuffy nose or to blow nose using the score), and Symptoms on waking in the morning (Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up); Lower scores indicate improvement in the rhinitis symptoms.
Measured: At Day 7 and Day 14
Number of Participants Showing Improvement for Daily Diary Questions (Q2 and Q4)
Participants were asked Q2 (How stuffed does your nose feel at this time?) and Q4 (How Breathing felt after the nasal strip was applied) of daily diary questions. Q2 was scored on 4 point scale where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms and Q4 on 11 point scale where -5=much worse, 0=same, 5=much better.
Measured: on first night (Night 1) of each daily diary question
Number of Participants Showing Improvement for VAS Scale Daily Diary Questions
Participants were asked following daily diary VAS scale questions a) How easy it was to breathe through your nose and b) How open their nose feels at this time. Both of these questions were scored using 100 mm VAS scale where, 0=extremely difficult, 100=extremely easy.
Measured: on first night (Night 1) of each daily diary question

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20091 Feb 2010

First posted13 May 2010 (estimated)
Study start1 Oct 2009
Primary completion1 Feb 2010
Study completion1 Feb 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Sleep DisordersStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01122849
Sponsor's protocol ID: B3570674
Status last verified: Jan 2018
First submitted: 11 May 2010
Last updated: 9 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Schenkel EJ, Ciesla R, Shanga GM. Effects of nasal dilator strips on subjective measures of sleep in subjects with chronic nocturnal nasal congestion: a randomized, placebo-controlled trial. Allergy Asthma Clin Immunol. 2018 Aug 27;14:34. doi: 10.1186/s13223-018-0258-5. eCollection 2018.
PubMed 30154874

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
Recruiting
Smith Magenis Syndrome and Autism Spectrum Disorders
Smith-Magenis Syndrome, Autism Spectrum Disorder
Not yet recruiting
Visual and Auditory Stimulation in Intensive Care Patients
Dyspnea, Sleep Quality
RecruitingPhase 4
Lemborexant in Delayed Sleep Phase Syndrome
Delayed Sleep Phase Syndrome
RecruitingObservational study
Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension
Sleep Apnea, Obstructive Sleep Apnea

All Sleep Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exploratory Subjective Sleep Study of a Prototype Nasal Dilator
ClinicalTrials.gov ID: NCT01122849
Acronym / sponsor ID: B3570674
Conditions: Sleep Disorders, Congestion, Nasal
Keywords: trouble with sleep, night time nasal congestion
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 1 Oct 2009
Primary completion: 1 Feb 2010 (actual)
Study completion: 1 Feb 2010 (actual)
First posted: 13 May 2010 (estimated)
Results: Posted 9 Apr 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this exploratory study is to evaluate the subjective measures of congestion and sleep quality in subjects who suffer from chronic nasal congestion and report trouble with their sleep.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Prototype Nasal Dilator	Experimental	Device: Prototype Nasal DilatorPrototype Nasal Dilator
Marketed Nasal Strip	Active comparator	Device: Marketed Nasal StripMarketed Nasal Strip
Placebo Nasal Strip	Placebo comparator	Device: Placebo Nasal StripPlacebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Subjects with leptorrhine noses
Subjects suffering from chronic nocturnal nasal congestion and report trouble with sleep

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Prototype Nasal DilatorPrototype nasal dilator AB2R11	Device	Prototype Nasal Dilator
Marketed Nasal StripBreathe Right Nasal Strip- Clear small/medium	Device	Marketed Nasal Strip
Placebo Nasal StripPlacebo strip	Device	Placebo Nasal Strip

Primary outcome

Change From Baseline in Mean Average Score Using Pittsburgh Insomnia Rating Scale (PIRS) in Q1, Q3, Q17 and Q18 at Day 7
Time frame: At Baseline and Day 7
The PIRS questionnaire had 3 sections (Section A [Q1 to Q12], Section B [Q13 to 16] and Section C [Q17 to Q20]). The following questions were asked from Section A : 1. One or more awakenings after getting to sleep and 3 Sleep that does not fully refresh you, and Section C: 17 Your sleep quality compared to most people and 18 Your satisfaction with your sleep. Section A question were scored as follows: 0= Not at all bothered, 1= slightly bothered, 2=moderately bothered, and 3= severely bothered. Section B, Q13 and 14 were scored as follows 0= Less than ½ hour, 1= between ½ to 1 hour, 2= between 1 to 3 hours and 3=more than 3 hours or I didn't sleep; Q15 and 16 were scored as 0=more than 7 hours, 1= between 4 to 7 hours, 2= between 2 to 4 hours, and 3=Less than 2 hours or I didn't sleep. Section C questions were scored as follows: 0=Excellent, 1=Good, 2=Fair, and 3=Poor. Lower PIRS score shows better sleep quality.
Change From Baseline in Mean Average Score Using Pittsburgh Insomnia Rating Scale (PIRS) in Q1, Q3, Q17 and Q18 at Day 14
Time frame: At Baseline and Day 14
Participant were asked questions related to their sleep using PIRS questionnaire. The PIRS questionnaire had 3 sections. Section A (Q1 to Q12), Section B (Q13 to Q16) and Section C (Q17 to Q20). Section A question were scored as follows: 0= Not at all bothered, 1= slightly bothered, 2=moderately bothered, and 3= severely bothered. Section B questions 13 and 14 were scored as follows 0= Less than ½ hour, 1= between ½ to 1 hour, 2= between 1 to 3 hours and 3=more than 3 hours or I didn't sleep; Questions 15 and 16 were scored as 0=more than 7 hours, 1= between 4 to 7 hours, 2= between 2 to 4 hours, and 3=Less than 2 hours or I didn't sleep. Section C questions were scored as follows: 0=Excellent, 1=Good, 2=Fair, and 3=Poor. Lower PIRS score shows better sleep quality.
Change From Baseline in Mean Average Score of NRQLQ (Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire) for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) on the) at Day 7
Time frame: At Baseline and Day 7
Participants scored all the domains of NRQLQ using same 7 points scale where 0=Not troubled and 6=extremely troubled. Sleep problems (difficulty getting sleep, unable to get a good night sleep or wake up during the night, restless [tossing and turning] and having to get up because stuffy nose or to blow nose using the score, scores range: Min-Max [0-24]), Sleep time problems (Nasal congestion or stuffy nose, sinus pressure or pain, runny nose, post-nasal drip [drainage down back of nose/throat], and headache, scores range: 0-30); Symptoms on waking in the morning (Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up, scores range:0-24); practical problems (have to avoid symptom triggers (such as dust, cigarette smoke, strong smells and perfumes, need to rub nose or eyes, and have to take medication, scores range: 0-18). Lower scores indicate improvement in the rhinitis symptoms.
Change From Baseline in Mean Average Score of NRQLQ (Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire) for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) on the) at Day 14
Time frame: At Baseline and Day 14
Participants scored all the domains of NRQLQ using same 7 points scale where 0=Not troubled and 6=extremely troubled. Sleep problems (difficulty getting sleep, unable to get a good night sleep or wake up during the night, restless [tossing and turning] and having to get up because stuffy nose or to blow nose using the score, scores range: Min-Max [0-24]), Sleep time problems (Nasal congestion or stuffy nose, sinus pressure or pain, runny nose, post-nasal drip [drainage down back of nose/throat], and headache, scores range: 0-30); Symptoms on waking in the morning (Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up, scores range:0-24); practical problems (have to avoid symptom triggers such as dust, cigarette smoke, strong smells and perfumes, need to rub nose or eyes, and have to take medication, scores range: 0-18). Lower scores indicate improvement in the rhinitis symptoms.
Change From Baseline in Mean Sum of 7 Questions of Congestion Quantifier 7 Questionnaire (CQ7) at Day 7
Time frame: At Baseline and Day 7
Participants answered following questions of CQ7 questionnaire: Q1 -How often did you have nasal stuffiness, blockage, or congestion?, Q2- How often did you have sinus pressure or pain in your face?, Q3-How often did you have to breathe through your mouth because you could not breathe through your nose?, Q4-How often did you have difficulty completely clearing your nose even after repeated blowing?, Q5-How often did any of these symptoms affect your ability to work, learn in school, or do the things you need to do?, Q6-How often did you awaken in the morning with nasal stuffiness, blockage, or congestion?, Q7-How often was your sleep affected by your nasal stuffiness, blockage, or congestion?. Their responses were scored using a 5 point scale where 0=none of the time; 1=a little of the time, 2=some of the time, 3=most of the time, 4=all of the time. Lower CQ7 scores reflect better nasal patency.
Change From Baseline in Mean Sum of 7 Questions of Congestion Quantifier 7 Questionnaire (CQ7) at Day 14
Time frame: At Baseline and Day 14
Participants answered following questions of CQ7 questionnaire: Q1 -How often did you have nasal stuffiness, blockage, or congestion?, Q2- How often did you have sinus pressure or pain in your face?, Q3-How often did you have to breathe through your mouth because you could not breathe through your nose?, Q4-How often did you have difficulty completely clearing your nose even after repeated blowing?, Q5-How often did any of these symptoms affect your ability to work, learn in school, or do the things you need to do?, Q6-How often did you awaken in the morning with nasal stuffiness, blockage, or congestion?, Q7-How often was your sleep affected by your nasal stuffiness, blockage, or congestion?. Their responses were scored using a 5 point scale where 0=none of the time; 1=a little of the time, 2=some of the time, 3=most of the time, 4=all of the time. Lowe CQ7 scores reflect better nasal patency.
Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Application at Bedtime on Day 7
Time frame: Day 7
Participants were asked how easy it was to breathe through their nose before and after strip application at bedtime. The participants scored their responses on 100 point VAS scale where 0 = extremely difficult to breathe and 100 = extremely easy to breathe. These responses were recorded daily.
Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Application at Bedtime on Day 14
Time frame: Day 14
Participants were asked how easy it was to breathe through their nose before and after strip application at bedtime. The participants scored their responses on 100 point VAS scale where 0 = extremely difficult to breathe and 100 = extremely easy to breathe. These responses were recorded daily.
Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Removal in Morning on Day 7
Time frame: Day 7
Participants were asked how easy it was to breathe through their nose before and after strip removal in morning. The participants scored their responses on 100 point VAS scale where 0 = extremely difficult to breathe and 100 = extremely easy to breathe. These responses were recorded daily.
Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Removal in Morning on Day 14.
Time frame: Day 14
Participants were asked how easy it was to breathe through their nose before and after strip removal in morning. The participants scored their responses on 100 point VAS scale where 0=extremely difficult to breathe and 100=extremely easy
Mean Score in Response to Daily Diary Questions (Q2 and Q4) at Bedtime on Day 7
Time frame: Day 7
Questions regarding nasal strips were asked to participants and scores were noted on daily basis. Participants were asked how stuffed their nose felt before and after strip application (Q2) and how breathing felt after strip was applied (Q4) at bedtime. For Q2 the participants scored their responses on a scale of 0 to 3 where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms. For Q4, participants scored their responses on a scale of -5 to 5 where -5=much worse, 0=same, and 5=much better (Q4 was asked after strip application only therefore no data for before application is available for Q4.)
Mean Score in Response to Daily Diary Questions (Q2 and Q4) at Bedtime on Day 14
Time frame: Day 14
Questions regarding nasal strips were asked to participants and scores were noted on daily basis. Participants were asked how stuffed their nose felt before and after strip application (Q2) and how breathing felt after strip was applied (Q4) at bedtime. For Q2, the participants scored their responses on a scale of 0 to 3 where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms. For Q4, participants scored their responses on a scale of -5 to 5 where -5=much worse, 0=same, and 5=much better (Q4 was asked after strip application only therefore no data for before application is available for question 4.)
Mean Score in Response to Daily Diary Questions (Q2 and Q4) in Morning on Day 7
Time frame: Day 7
Questions regarding nasal strips were asked to participants and scores were noted on daily basis. Participants were asked how stuffed their nose felt before and after strip removal (Q2) and how breathing felt after strip was removed (Q4) in morning. For Q2 the participants scored their responses on a scale of 0 to 3 where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms. For Q4, participants scored their responses on a scale of -5 to 5 where -5=much worse, 0=same, and 5=much better. (Q4 was asked after strip removal only therefore no data for before removal is available for question 4.)
Mean Score in Response to Daily Diary Questions (Q2 and Q4) in Morning on Day 14
Time frame: Day 14
Questions regarding nasal strips were asked to participants and scores were noted on daily basis. Participants were asked how stuffed their nose felt before and after strip removal (Q2) and how breathing felt after strip was removed (Q4) in morning. For Q2 the participants scored their responses on a scale of 0 to 3 where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms. For Q4, participants scored their responses on a scale of -5 to 5 where -5=much worse, 0=same, and 5=much better (Q4 was asked after strip removal only therefore no data for before removal is available for question 4.)

12 secondary outcomes

Summary for Other Questions of PIRS Questionnaire
Time frame: At Day 7 and Day 14
Summary of Other Daily Diary VAS Scale Questions Before and After Strip Application at Bedtime
Time frame: At Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day 13
Summary of Other Daily Diary VAS Scale Questions Before and After Strip Removal in Morning
Time frame: At Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day 13
Summary of Other Daily Diary VAS Scale Questions Before and After Strip Application at Bedtime
Time frame: At Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day 13
Summary of Other Daily Diary VAS Scale Questions Before and After Strip Removal in Morning.
Time frame: At Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day 13
Summary of Daily Diary Questions Before and After Strip Application at Bedtime
Time frame: At Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day 13
Summary of Daily Dairy Questions Before and After Strip Removal in Morning
Time frame: At Day 1, Day 2, day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day 13
Summary of Daily Diary Questions at Bed Time (After Strip Application) and in Morning (After Strip Removal).
Time frame: At Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day13
Change From Baseline in Mean Average Score of NRQLQ for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) on the) at Day 7 and Day 14 in Participants With the Risk of Sleep Apnea.
Time frame: At Day 7 and at Day 14
Number of Participants Showing Improvement for Sleep Problems and Symptoms on Waking in the Morning Domain of the NRQLQ
Time frame: At Day 7 and Day 14
Number of Participants Showing Improvement for Daily Diary Questions (Q2 and Q4)
Time frame: on first night (Night 1) of each daily diary question
Number of Participants Showing Improvement for VAS Scale Daily Diary Questions
Time frame: on first night (Night 1) of each daily diary question

Results and safety

Results posted to the registry on 9 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Marketed Nasal Strip	20	20
Placebo Nasal Strip	21	21
Prototype Nasal Strip	20	20

Primary outcome: Change From Baseline in Mean Average Score Using Pittsburgh Insomnia Rating Scale (PIRS) in Q1, Q3, Q17 and Q18 at Day 7

Time frame: At Baseline and Day 7. Least squares mean (95% Confidence Interval). Unit: Score on a scale

Measure	Marketed Nasal Strip n = 20	Placebo Nasal Strip n = 20	Prototype Nasal Strip n = 19
Q1	-0.911 (-1.21 to -0.61)	-0.694 (-0.99 to -0.40)	-1.032 (-1.34 to -0.72)
Q3	-1.004 (-1.37 to -0.63)	-0.708 (-1.07 to -0.34)	-0.947 (-1.33 to -0.56)
Q17	-0.721 (-1.01 to -0.43)	-0.349 (-0.63 to -0.07)	-0.539 (-0.84 to -0.24)
Q18	-0.643 (-0.91 to -0.38)	-0.234 (-0.50 to 0.03)	-0.697 (-0.98 to -0.42)

Marketed Nasal Strip vs Prototype Nasal Strip: Least Square (LS) Mean difference: -0.12 (95% CI -0.52 to 0.28), p = 0.5456, ANCOVA
Placebo Nasal Strip vs Prototype Nasal Strip: LS mean difference: -0.34 (95% CI -0.75 to 0.07), p = 0.1029, ANCOVA
Marketed Nasal Strip vs Placebo Nasal Strip: LS mean difference: 0.22 (95% CI -0.19 to 0.62), p = 0.2879, ANCOVA

Population analysed: Analysis for this outcome was performed on intent-to-treat (ITT) population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.

Primary outcome: Change From Baseline in Mean Average Score Using Pittsburgh Insomnia Rating Scale (PIRS) in Q1, Q3, Q17 and Q18 at Day 14

Time frame: At Baseline and Day 14. Least squares mean (95% Confidence Interval). Unit: Score on a scale

Measure	Marketed Nasal Strip n = 20	Placebo Nasal Strip n = 20	Prototype Nasal Strip n = 19
Q1 (One or more awakenings after getting to sleep)	-1.047 (-1.36 to -0.74)	-0.844 (-1.14 to -0.54)	-1.157 (-1.48 to -0.84)
Q3 (Sleep that does not fully refresh you)	-1.306 (-1.69 to -0.92)	-0.917 (-1.30 to -0.54)	-1.104 (-1.50 to -0.70)
Q17 (Your sleep quality compared to most people)	-0.714 (-1.04 to -0.39)	-0.359 (-0.68 to -0.04)	-0.837 (-1.17 to -0.50)
Q18 (Your satisfaction with your sleep)	-0.873 (-1.18 to -0.57)	-0.464 (-0.76 to -0.16)	-0.951 (-1.27 to -0.63)

Marketed Nasal Strip vs Prototype Nasal Strip: LS Mean Difference: -0.11 (95% CI -0.52 to 0.30), p = 0.5958, ANCOVA
Placebo Nasal Strip vs Prototype Nasal Strip: LS Mean Difference: -0.31 (95% CI -0.73 to 0.11), p = 0.1429, ANCOVA
Marketed Nasal Strip vs Placebo Nasal Strip: LS Mean Difference: 0.20 (95% CI -0.21 to 0.62), p = 0.3348, ANCOVA

Primary outcome: Change From Baseline in Mean Average Score of NRQLQ (Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire) for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) on the) at Day 7

Time frame: At Baseline and Day 7. Least squares mean (95% Confidence Interval). Unit: Score on a Scale

Measure	Marketed Nasal Strip n = 20	Placebo Nasal Strip n = 20	Prototype Nasal Strip n = 19
Sleep Problems	-7.398 (-9.44 to -5.36)	-4.194 (-6.18 to -2.21)	-6.563 (-8.71 to -4.42)
Sleep time Problems	-7.494 (-9.99 to -5.00)	-5.638 (-8.09 to -3.19)	-8.212 (-10.81 to -5.61)
Symptoms on walking in the morning	-7.196 (-9.28 to -5.11)	-4.074 (-6.13 to -2.02)	-7.905 (-10.09 to -5.72)
Practical Problems	-2.774 (-4.02 to -1.52)	-2.277 (-3.51 to -1.04)	-3.079 (-4.38 to -1.78)

Marketed Nasal Strip vs Prototype Nasal Strip: LS Mean Difference: 0.84 (95% CI -1.92 to 3.59), p = 0.5462, ANCOVA
Placebo Nasal Strip vs Prototype Nasal Strip: LS Mean Difference: -2.37 (95% CI -5.16 to 0.42), p = 0.0942, ANCOVA
Marketed Nasal Strip vs Placebo Nasal Strip: LS Mean Difference: 3.20 (95% CI 0.48 to 5.93), p = 0.0221, ANCOVA

Population analysed: Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.

Primary outcome: Change From Baseline in Mean Average Score of NRQLQ (Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire) for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) on the) at Day 14

Time frame: At Baseline and Day 14. Least squares mean (95% Confidence Interval). Unit: Score on a scale

Measure	Marketed Nasal Strip n = 20	Placebo Nasal Strip n = 20	Prototype Nasal Strip n = 19
Sleep Problems	-7.624 (-9.68 to -5.57)	-5.738 (-7.74 to -3.74)	-7.051 (-9.21 to -4.89)
Sleep Time Problems	-8.746 (-11.24 to -6.26)	-7.051 (-9.49 to -4.61)	-6.768 (-9.36 to -4.18)
Symptoms on waking in the morning	-7.858 (-9.90 to -5.81)	-5.318 (-7.33 to -3.30)	-8.001 (-10.14 to -5.86)
Practical Problems	-3.591 (-4.74 to -2.44)	-3.208 (-4.34 to -2.07)	-3.054 (-4.25 to -1.86)

Marketed Nasal Strip vs Prototype Nasal Strip: LS Mean Difference: 0.57 (95% CI -2.20 to 3.35), p = 0.6804, ANCOVA
Placebo Nasal Strip vs Prototype Nasal Strip: LS Mean Difference: -1.31 (95% CI -4.12 to 1.49), p = 0.3524, ANCOVA
Marketed Nasal Strip vs Placebo Nasal Strip: LS Mean Difference: 1.89 (95% CI -0.86 to 4.63), p = 0.1739, ANCOVA

Population analysed: Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.

12 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Marketed Nasal Strip	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Placebo Nasal Strip	0 of 21 (0%)	1 of 21 (4.8%)	0 of 21
Prototype Nasal Dilator	0 of 19 (0%)	0 of 19 (0%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30154874Schenkel EJ, Ciesla R, Shanga GM. Effects of nasal dilator strips on subjective measures of sleep in subjects with chronic nocturnal nasal congestion: a randomized, placebo-controlled trial. Allergy Asthma Clin Immunol. 2018 Aug 27;14:34. doi: 10.1186/s13223-018-0258-5. eCollection 2018.

Related trials for Sleep Disorders

Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
Recruiting
Smith Magenis Syndrome and Autism Spectrum Disorders
Smith-Magenis Syndrome, Autism Spectrum Disorder
Not yet recruiting
Visual and Auditory Stimulation in Intensive Care Patients
Dyspnea, Sleep Quality
RecruitingPhase 4
Lemborexant in Delayed Sleep Phase Syndrome
Delayed Sleep Phase Syndrome
RecruitingObservational study
Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension
Sleep Apnea, Obstructive Sleep Apnea

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Prototype Nasal Dilator and Marketed Nasal Strip in people with Sleep Disorders and Congestion, Nasal, run by GlaxoSmithKline at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Mean Average Score Using Pittsburgh Insomnia Rating Scale (PIRS) in Q1, Q3, Q17 and Q18 at Day 7 (time frame: At Baseline and Day 7). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01122849, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2018.