An interventional study of NeilMed nose and sinus irrigation in Obstructive Sleep Apnea, sponsored by Bridgeport Hospital. Status unknown at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2010-05-12.
Sponsored by Bridgeport Hospital · Not applicable, Interventional, and Treatment
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.
2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.
This study's planned enrollment of 30 is below the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →Bridgeport Hospital is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
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.
Time frame: 4 weeks
Epworth Sleepiness Scale
The Epworth Sleepiness Scale is a self administered questionnaire that measures subjective daytime hypersomnia on a scale of 0 to 24.
Time frame: 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.
Time frame: 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.
Time frame: 4 weeks
This study is status unknown, as verified in May 2010. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bridgeport Hospital