The Impact of Daily Sinus Irrigation on Nasal Symptoms in Continuous Positive Airway Pressure (CPAP) Users - A Pilot Study
Recruitment status was Recruiting
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:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
- RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]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.
- Epworth Sleepiness Scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]The Epworth Sleepiness Scale is a self administered questionnaire that measures subjective daytime hypersomnia on a scale of 0 to 24.
- SF-36 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]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.
- CPAP compliance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||March 2011|
|Estimated Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
No Intervention: CPAP with heated humidification
Standard of care
Device: NeilMed nose and sinus irrigation
Saline irrigation used daily plus CPAP with heated humidification for 4 weeks
Please refer to this study by its ClinicalTrials.gov identifier: NCT01121445
|United States, Connecticut|
|Bridgeport, Connecticut, United States, 06610|
|Contact: Jeff S Kwon, MD 203-384-4142 firstname.lastname@example.org|
|Principal Investigator:||Jeff S Kwon, MD||Bridgeport Hospital|