The Impact of Daily Sinus Irrigation on Nasal Symptoms in Continuous Positive Airway Pressure (CPAP) Users - A Pilot Study

Not Applicable

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: NeilMed nose and sinus irrigation

• Registration Number: NCT01121445
• Lead Sponsor: Bridgeport Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-05
• Study Start: 2010-05
• Study First Submitted: 2010-05-06
• Study First Submitted QC: 2010-05-11
• Last Update Submitted: 2010-05-11
• Study First Posted: 2010-05-12
• Last Update Posted: 2010-05-12
• Primary Completion: 2011-03
• Study Completion: 2011-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CPAP with heated humidification	NeilMed nose and sinus irrigation	Standard of care

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Bridgeport Hospital; 🇺🇸 Bridgeport, Connecticut, United States