The Impact of Daily Sinus Irrigation on Nasal Symptoms in Continuous Positive Airway Pressure (CPAP) Users - A Pilot Study
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|ClinicalTrials.gov Identifier: NCT01121445|
Recruitment Status : Unknown
Verified May 2010 by Bridgeport Hospital.
Recruitment status was: Recruiting
First Posted : May 12, 2010
Last Update Posted : May 12, 2010
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Device: NeilMed nose and sinus irrigation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||March 2011|
|Estimated Study Completion Date :||March 2011|
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
- 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.
- Epworth Sleepiness Scale [ Time Frame: 4 weeks ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01121445
|United States, Connecticut|
|Bridgeport, Connecticut, United States, 06610|
|Contact: Jeff S Kwon, MD 203-384-4142 email@example.com|
|Principal Investigator:||Jeff S Kwon, MD||Bridgeport Hospital|