The Impact of Daily Sinus Irrigation on Nasal Symptoms in Continuous Positive Airway Pressure (CPAP) Users - A Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obstructive Sleep Apnea
- Sponsor
- Bridgeport Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire)
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Epworth Sleepiness Scale(4 weeks)
- SF-36(4 weeks)
- CPAP compliance(4 weeks)