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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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CPAP with heated humidification

Standard of care

Group Type NO_INTERVENTION

NeilMed nose and sinus irrigation

Intervention Type DEVICE

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

Interventions

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NeilMed nose and sinus irrigation

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No