Comparison of Nasal Positive End Expiratory Pressure Valve to Dental Device as an Alternative Treatment for Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea; Adverse Effects

• Registration Number: NCT01553383
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

Determine the clinical efficacy in terms of Apnea Hypopnea Index (AHI), excessive daytime sleepiness (EDS), nocturnal oxygenation of a nasal Positive end-expiratory pressure (PEEP) valve "Provent" in obstructive sleep apnea. The hypothesis is the efficacy will be better than dental device.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-01
• Study First Submitted QC: 2012-03-13
• Study First Posted: 2012-03-14
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-05
• Last Update Posted: 2013-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Symptomatic patients confirmed of OSA by sleep study (PSG according to AASM criteria or validated level 3 portable monitoring devices with AHI > 10/hr)
• Not using CPAP for any reasons or patients on dental device but would like to try alternative treatments for OSA.
• Able to sign informed consent and use the PEEP nasal valve.
• Age between 18-65 years old.
• Willing to attend follow up.

Exclusion Criteria

• Known nasal problems like deformities or significant rhinitis affecting application of PEEP nasal valve.
• Unable to sign consent or use PEEP nasal valve.
• Significant or unstable co-morbidities requiring other forms of treatment for OSA as priority.
• Coexisting sleep disordered breathing condition other than OSA requiring more complex treatment. E.g. central sleep apnea, significant Cheyne Stokes respiration or hypoventilation syndrome.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Apnea Hypopnea Index (AHI)	1 month

Secondary Outcome Measures

Name	Time	Method
side effects as a measure of tolerability	1 month

Trial Locations

Locations (1)

Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK; 🇭🇰 Shatin, Hong Kong