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

The Chinese University of Hong Kong

Status

Completed

Conditions

Adverse Effects

Obstructive Sleep Apnea

Treatments

Device: nasal peep valve "Provent"

Study type

Interventional

Funder types

Other

Identifiers

NCT01553383

CREC2012.037

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.