Sleep DisturbanceNCT05312723
Sleep Disturbance in Chronic Rhinitis
An observational study of Sleep Disturbance, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The aim of this study is to evaluate the characteristic of sleep disturbance in allergic and non-allergic rhinitis in Dr. Cipto Mangunkusumo Hospital, Jakarta. A cross sectional analytic descriptive study with consecutive sampling was performed. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sleep Disturbance
- How many people
- 22 participants
- Where
- 1 siteIndonesia
- Study dates
- 15 Mar 2020to 15 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Allergic and non-allergic rhinitis patients
Who may be able to join
- All male and female between 18-60 years old with chronic rhinitis symptoms and sleep disorder
- Did not receive intranasal steroid within the last one month
- Have psychiatric disorder
Who cannot join
- Polyp
- Nasal or sinonasal tumor
- Septum deviation
- Chronic rhinosinusitis
- Adenoid hypertrophy
- Tonsil hypertrophy
- Macroglossia
- Oropharyngeal tumor
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
RSUPN Dr. Cipto Mangunkusumo
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: Sleep Disturbance in Chronic Rhinitis: Evaluation of Nasal Symptoms, Sleep Disorder Questionnaires, and Sleep Architecture in Allergic & Non-Allergic Rhinitis in Dr. Cipto Mangunkusumo Hospital
The aim of this study is to evaluate the characteristic of sleep disturbance in allergic and non-allergic rhinitis in Dr. Cipto Mangunkusumo Hospital, Jakarta. A cross sectional analytic descriptive study with consecutive sampling was performed. A total of 22 chronic rhinitis patients, consisted of 11 allergic and 11 non-allergic rhinitis were evaluated of their sleep disturbance's characteristics.
Read the detailed description
At first, all recruited subjects were evaluated for total nasal symptom scores (TNSS) and nasal obstruction symptoms evaluation scores (NOSE). Sleep disorder was assessed using Epworth Sleepiness Scale (ESS), Pittsburg Sleep Quality Index (PSQI) questionnaires, and polysomnography (PSG). Both the allergic and non-allergic rhinitis groups will be compared in terms of their sleep disturbance characteristics (from comparing ESS, PSQI, and PSG results).
- Conditions
- Sleep Disturbance
- Keywords
- allergic, nasal congestion, daytime sleepiness, polysomnography
- Medical subject headings
- Parasomnias, Nasal Obstruction, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rhinitis allergy | Patients with rhinitis symptoms and positive skin pric test to one or more allergens. | |
| Non-rhinitis allergy | Patients with rhinitis symptoms and negative skin pric test to one or more allergens. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean value of TNSS based on VAS symptoms
Clinical symptoms was evaluated by visual analogue scale (VAS) based on total nasal symptoms score (TNSS). Total nasal symptoms score are based on four symptoms, which are rhinorrea, sneezing, itchy nose, and nose obstruction. Each symptom will be given a score between 1 (most mild symptom) until 5 (most severe symptom). The minum score for VAS based on TNSS is 4 (most mild symptom) and the maximum score is 40 (most severe symptom). VAS score less than five indicates a controlled rhinitis symptoms, while ≥ 5 indicates that symptoms are not controlled.
Measured: Evaluation is done at Day 1(cross-sectional)
Nasal obstruction symtpms evaluation (NOSE) score
Nasal obstruction symptoms was evaluated by NOSE score. It evaluates 5 items that indicates nasal obstruction symptoms that was experienced in the past 1 month. Each item has a score range from 0 to 20. It has a minimum score of 0 and a maximum score of 100. Score 5-25 indicates mild nasal obstruction, score 30-50 indicates moderate nasal obstruction, score 55-75 indicates severe nasal obstruction, and score > 80 indicates extreme nasal obstruction.
Measured: Evaluation is done at Day 1 (cross-sectional)
Sleep quality from Epworth sleepiness scale (ESS)
Sleep quality assessed by Epworth sleepiness scale. ESS is a self-administered questionnaire consisted of 8 questions. It assessed the chances of falling asleep while engaged in different activities. Each item scored 0-3, with a minimum score of 0 (low normal daytime sleepiness) and a maximum score of 24 (severe daytime sleepiness). In this study, the cut off is score 5-9 indicates mild daytime sleepiness and score > 10 indicates severe daytime sleepiness.
Measured: Evaluation is done at Day 1 (cross-sectional)
Sleep quality from Pittsburg Sleep Quality Index (PSQI)
Sleep quality assessed by Pittsburg Sleep Quality Index. PSQI consisted of 10 questions. These 10 questions were divided to 7 components, including subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction. Each component score range from 0-23. Total score can range from 0 to 21. Score < 5 indicates good sleep quality and > 5 indicates poor sleep quality
Measured: Evaluation is done at Day 1 (cross-sectional)
Objective sleep measurement using polysomnography (PSG)
Sleep parameters were objectively measured using polysomnography (PSG). Sleep architecture was assessed using non-rapid eye movement (NREM)/ rapid eye movement (REM) and respiratory analysis was assessed using respiratory disturbance index - rapid eye movement (RDI-REM) and respiratory effort related arousals (RERA). All the parameters will be presented as numeric data.
Measured: Evaluation is done at Day 1 (cross-sectional)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start15 Mar 2020
- Primary completion15 Aug 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina Irawati, Universitas Indonesia
- Investigators
- Nina Irawati, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312723
- Sponsor's protocol ID
- 20-01-0074
- Status last verified
- Apr 2022
- First submitted
- 28 Mar 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disturbance in Chronic Rhinitis: Evaluation of Nasal Symptoms, Sleep Disorder Questionnaires, and Sleep Architecture in Allergic & Non-Allergic Rhinitis in Dr. Cipto Mangunkusumo Hospital
- ClinicalTrials.gov ID
- NCT05312723
- Acronym / sponsor ID
- 20-01-0074
- Conditions
- Sleep Disturbance
- Keywords
- allergic, nasal congestion, daytime sleepiness, polysomnography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the characteristic of sleep disturbance in allergic and non-allergic rhinitis in Dr. Cipto Mangunkusumo Hospital, Jakarta. A cross sectional analytic descriptive study with consecutive sampling was performed. A total of 22 chronic rhinitis patients, consisted of 11 allergic and 11 non-allergic rhinitis were evaluated of their sleep disturbance's characteristics.
Detailed description
At first, all recruited subjects were evaluated for total nasal symptom scores (TNSS) and nasal obstruction symptoms evaluation scores (NOSE). Sleep disorder was assessed using Epworth Sleepiness Scale (ESS), Pittsburg Sleep Quality Index (PSQI) questionnaires, and polysomnography (PSG). Both the allergic and non-allergic rhinitis groups will be compared in terms of their sleep disturbance characteristics (from comparing ESS, PSQI, and PSG results).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rhinitis allergy | – | –Patients with rhinitis symptoms and positive skin pric test to one or more allergens. |
| Non-rhinitis allergy | – | –Patients with rhinitis symptoms and negative skin pric test to one or more allergens. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Allergic and non-allergic rhinitis patients
Key inclusion criteria (3 listed)
- All male and female between 18-60 years old with chronic rhinitis symptoms and sleep disorder
- Did not receive intranasal steroid within the last one month
- Have psychiatric disorder
Key exclusion criteria (8 listed)
- Polyp
- Nasal or sinonasal tumor
- Septum deviation
- Chronic rhinosinusitis
- Adenoid hypertrophy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean value of TNSS based on VAS symptoms
Time frame: Evaluation is done at Day 1(cross-sectional)
Clinical symptoms was evaluated by visual analogue scale (VAS) based on total nasal symptoms score (TNSS). Total nasal symptoms score are based on four symptoms, which are rhinorrea, sneezing, itchy nose, and nose obstruction. Each symptom will be given a score between 1 (most mild symptom) until 5 (most severe symptom). The minum score for VAS based on TNSS is 4 (most mild symptom) and the maximum score is 40 (most severe symptom). VAS score less than five indicates a controlled rhinitis symptoms, while ≥ 5 indicates that symptoms are not controlled.
Nasal obstruction symtpms evaluation (NOSE) score
Time frame: Evaluation is done at Day 1 (cross-sectional)
Nasal obstruction symptoms was evaluated by NOSE score. It evaluates 5 items that indicates nasal obstruction symptoms that was experienced in the past 1 month. Each item has a score range from 0 to 20. It has a minimum score of 0 and a maximum score of 100. Score 5-25 indicates mild nasal obstruction, score 30-50 indicates moderate nasal obstruction, score 55-75 indicates severe nasal obstruction, and score > 80 indicates extreme nasal obstruction.
Sleep quality from Epworth sleepiness scale (ESS)
Time frame: Evaluation is done at Day 1 (cross-sectional)
Sleep quality assessed by Epworth sleepiness scale. ESS is a self-administered questionnaire consisted of 8 questions. It assessed the chances of falling asleep while engaged in different activities. Each item scored 0-3, with a minimum score of 0 (low normal daytime sleepiness) and a maximum score of 24 (severe daytime sleepiness). In this study, the cut off is score 5-9 indicates mild daytime sleepiness and score > 10 indicates severe daytime sleepiness.
Sleep quality from Pittsburg Sleep Quality Index (PSQI)
Time frame: Evaluation is done at Day 1 (cross-sectional)
Sleep quality assessed by Pittsburg Sleep Quality Index. PSQI consisted of 10 questions. These 10 questions were divided to 7 components, including subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction. Each component score range from 0-23. Total score can range from 0 to 21. Score < 5 indicates good sleep quality and > 5 indicates poor sleep quality
Objective sleep measurement using polysomnography (PSG)
Time frame: Evaluation is done at Day 1 (cross-sectional)
Sleep parameters were objectively measured using polysomnography (PSG). Sleep architecture was assessed using non-rapid eye movement (NREM)/ rapid eye movement (REM) and respiratory analysis was assessed using respiratory disturbance index - rapid eye movement (RDI-REM) and respiratory effort related arousals (RERA). All the parameters will be presented as numeric data.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
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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.
Nina Irawati principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disturbance, run by Universitas Indonesia at 1 site in Indonesia.
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 3 inclusion and 8 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 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean value of TNSS based on VAS symptoms (time frame: Evaluation is done at Day 1(cross-sectional)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2022.