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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:
Information provided by (Responsible Party):
To Kin Wang, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01553383
First received: March 1, 2012
Last updated: April 5, 2013
Last verified: April 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Apnea Hypopnea Index (AHI) [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • side effects as a measure of tolerability [ Time Frame: 1 month ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 1, 2012
Last Updated: April 5, 2013
Health Authority: Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:
OSA

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

ClinicalTrials.gov processed this record on May 16, 2013