Obstructive Sleep ApneaNCT01121445
The Impact of Daily Sinus Irrigation on Nasal Symptoms in Continuous Positive Airway Pressure (CPAP) Users - A Pilot Study
A study testing NeilMed nose and sinus irrigation in people with Obstructive Sleep Apnea, run by Bridgeport Hospital at 1 site in United States.
Trial summary
Continuous positive airway pressure (CPAP) is the most commonly used treatment for obstructive sleep apnea. Nasal symptoms such as dryness, itching and congestion are common in CPAP users. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- NeilMed nose and sinus irrigation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Mar 2011
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Apnea/hypopnea index ≥ 10
- A documented successful CPAP titration
Who cannot join
- Conditions that in the judgment of the investigator would interfere with subject participation in the study
- History of sinus or nasal surgery
- History of psychiatric illness
- Use of sleep aids, sedatives or narcotics
- Use of oral of subcutaneous anti-coagulants (i.e. warfarin, enoxaparin)
- Bilevel or other nocturnal ventilation other than CPAP
Show all 11Show fewer
- Use of supplemental oxygen
- Pregnancy or lactating
- Inability or unwillingness to provide informed consent
- Inability to perform baseline measurements
- Inability to be contacted by phone
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Bridgeport Hospital
Bridgeport, Connecticut, 06610
Jeff S Kwon, MD, 203-384-4142, jkw109@gmail.com
About this study
Continuous positive airway pressure (CPAP) is the most commonly used treatment for obstructive sleep apnea. Nasal symptoms such as dryness, itching and congestion are common in CPAP users. Nasal and sinus saline irrigation has been shown to improve these symptoms in individuals with chronic nasal congestion and sinusitis. This is an 8 week study that investigates whether daily saline nasal and sinus irrigation reduces nasal symptoms in patients using CPAP, improves quality of life and CPAP compliance.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- NeilMed nose and sinus irrigation
- Keywords
- Sleep apnea, CPAP, Saline irrigation
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeilMed nose and sinus irrigationDevice
Saline irrigation used daily plus CPAP with heated humidification for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| CPAP with heated humidification | No intervention | Standard of care Receives: Device: NeilMed nose and sinus irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire)
A 28-item, self administered questionnaire measuring nasal symptoms and other domains, including activity limitations and eye symptoms. Subjects will be asked to rate their symptoms on a 7-point scale (0=no impairment, 6=severely impaired). Change in RQLQ with daily saline irrigation in CPAP users is the primary outcome of interest.
Measured: 4 weeks
Secondary outcomes (3)
Epworth Sleepiness Scale
The Epworth Sleepiness Scale is a self administered questionnaire that measures subjective daytime hypersomnia on a scale of 0 to 24.
Measured: 4 weeks
SF-36
The Medical Outcome Study 36-Item Short Form health survey (SF-36) is a 36-item questionnaire which measures 8 domains of health: physical functioning, physical problems, emotional problems, social functioning, mental health, energy/vitality, pain, and general perception of health status. This questionnaire has been used as a validated measure of change in the quality of life of OSA patients on CPAP therapy.
Measured: 4 weeks
CPAP compliance
CPAP card compliance data will be measured to determine if use of daily sinus rinse is associated with an increase in CPAP use. The % of days CPAP used over 4 weeks and the average number of hours of CPAP use per night are the outcomes of interest.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startMay 2010
- Primary completionMar 2011 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bridgeport Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- NeilMed Pharmaceuticals
- Investigators
- Jeff S Kwon, MD, Principal investigator, Bridgeport Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121445
- Sponsor's protocol ID
- IRB #041001
- Status last verified
- May 2010
- First submitted
- 6 May 2010
- Last updated
- 12 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Daily Sinus Irrigation on Nasal Symptoms in Continuous Positive Airway Pressure (CPAP) Users - A Pilot Study
- ClinicalTrials.gov ID
- NCT01121445
- Acronym / sponsor ID
- IRB #041001
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Sleep apnea, CPAP, Saline irrigation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Bridgeport HospitalUniversity, hospital or other
- Collaborators
- NeilMed Pharmaceuticals
- Study start
- May 2010
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 12 May 2010 (estimated)
- 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.
Continuous positive airway pressure (CPAP) is the most commonly used treatment for obstructive sleep apnea. Nasal symptoms such as dryness, itching and congestion are common in CPAP users. Nasal and sinus saline irrigation has been shown to improve these symptoms in individuals with chronic nasal congestion and sinusitis. This is an 8 week study that investigates whether daily saline nasal and sinus irrigation reduces nasal symptoms in patients using CPAP, improves quality of life and CPAP compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPAP with heated humidification | No intervention | Device: NeilMed nose and sinus irrigationStandard of care |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18
- Apnea/hypopnea index ≥ 10
- A documented successful CPAP titration
Key exclusion criteria (11 listed)
- Conditions that in the judgment of the investigator would interfere with subject participation in the study
- History of sinus or nasal surgery
- History of psychiatric illness
- Use of sleep aids, sedatives or narcotics
- Use of oral of subcutaneous anti-coagulants (i.e. warfarin, enoxaparin)
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 |
|---|---|---|
| NeilMed nose and sinus irrigationSaline irrigation used daily plus CPAP with heated humidification for 4 weeks | Device | CPAP with heated humidification |
Primary outcome
RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire)
Time frame: 4 weeks
A 28-item, self administered questionnaire measuring nasal symptoms and other domains, including activity limitations and eye symptoms. Subjects will be asked to rate their symptoms on a 7-point scale (0=no impairment, 6=severely impaired). Change in RQLQ with daily saline irrigation in CPAP users is the primary outcome of interest.
3 secondary outcomes
Epworth Sleepiness Scale
Time frame: 4 weeks
SF-36
Time frame: 4 weeks
CPAP compliance
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2010.
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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.
Jeff S Kwon, MD principal investigator
Bridgeport Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeilMed nose and sinus irrigation in people with Obstructive Sleep Apnea, run by Bridgeport Hospital at 1 site 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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 12 May 2010. 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 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) (time frame: 4 weeks). 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 12 May 2010; AzTrials last refreshed its copy on 8 Nov 2026.