The Impact of Daily Sinus Irrigation on Nasal Symptoms in Continuous Positive Airway Pressure (CPAP) Users - A Pilot Study

Study Overview
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Brief Summary
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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
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: NeilMed nose and sinus irrigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 Apnea/hypopnea index ≥ 10 A documented successful CPAP titration Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: CPAP with heated humidification<br>Standard of care | Device: NeilMed nose and sinus irrigation<br>* Saline irrigation used daily plus CPAP with heated humidification for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epworth Sleepiness Scale | The Epworth Sleepiness Scale is a self administered questionnaire that measures subjective daytime hypersomnia on a scale of 0 to 24. | 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. | 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. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep apnea, CPAP, Saline irrigation