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
• Interventions: Device: nasal peep valve "Provent"

• 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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dental device	nasal peep valve "Provent"	"Provent" nasal peep valve vs dental device
CPAP	nasal peep valve "Provent"	continuous positive airway pressure "CPAP" vs nasap peep valve "Provent"

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