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OpenTrials
Completed

NCT Number: NCT01553383

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Adverse Effects Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK

Shatin, Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nasal peep valve "Provent"

Device

application of nasal peep valve vs dental device and cpap

Primary outcomes

  1. Apnea Hypopnea Index (AHI)

    Time frame: 1 month

Secondary outcomes

  1. side effects as a measure of tolerability

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 14, 2012
Registry last updated
Apr 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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