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

Bridgeport Hospital30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Obstructive Sleep Apnea

Interventions

NeilMed nose and sinus irrigationDEVICE

Saline irrigation used daily plus CPAP with heated humidification for 4 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Bridgeport Hospital

Bridgeport, Connecticut, United States

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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