Obstructive Sleep Apnea
Conditions
Keywords
Sleep apnea, CPAP, Saline irrigation
Brief 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. 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.
Interventions
DEVICENeilMed nose and sinus irrigation
Saline irrigation used daily plus CPAP with heated humidification for 4 weeks
Sponsors
NeilMed Pharmaceuticals
Bridgeport Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Epworth Sleepiness Scale | 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 | 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 | 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. |
Countries
United States
Outcome results
None listed