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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01553383
First Posted: March 14, 2012
Last Update Posted: April 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
To Kin Wang, Chinese University of Hong Kong
  Purpose
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.

Condition Intervention
Obstructive Sleep Apnea Adverse Effects Device: nasal peep valve "Provent"

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Nasal Positive End Expiratory Pressure Valve to Dental Device as an Alternative Treatment for OSA

Resource links provided by NLM:


Further study details as provided by To Kin Wang, Chinese University of Hong Kong:

Primary Outcome Measures:
  • Apnea Hypopnea Index (AHI) [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • side effects as a measure of tolerability [ Time Frame: 1 month ]

Enrollment: 200
Study Start Date: February 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dental device
"Provent" nasal peep valve vs dental device
Device: nasal peep valve "Provent"
application of nasal peep valve vs dental device and cpap
Active Comparator: CPAP
continuous positive airway pressure "CPAP" vs nasap peep valve "Provent"
Device: nasal peep valve "Provent"
application of nasal peep valve vs dental device and cpap

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01553383


Locations
Hong Kong
Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK
Shatin, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
  More Information

Responsible Party: To Kin Wang, Associate consultant, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01553383     History of Changes
Other Study ID Numbers: CREC2012.037
First Submitted: March 1, 2012
First Posted: March 14, 2012
Last Update Posted: April 8, 2013
Last Verified: April 2013

Keywords provided by To Kin Wang, Chinese University of Hong Kong:
OSA

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases