Positive Pressure Treatment of Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Information provided by:
Philips Respironics
ClinicalTrials.gov Identifier:
NCT00636181
First received: February 6, 2008
Last updated: June 9, 2009
Last verified: June 2009
  Purpose

Six month at home positive pressure therapy study; which mode of therapy will lead to better adherence and patient outcomes?


Condition Intervention
Obstructive Sleep Apnea Hypopnea Syndrome
Device: Auto AFlex
Device: Auto CPAP
Device: CPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Positive Airway Pressure Initiation: Impact of Therapy Mode and Titration Process on Adherence and Outcomes

Resource links provided by NLM:


Further study details as provided by Philips Respironics:

Primary Outcome Measures:
  • Adequate reduction of apnea hypopnea index from baseline. [ Time Frame: 180 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average hours of nightly use. [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  • Psychomotor vigilance testing,Functional outcomes of sleep questionnaire, Epworth Sleepiness Scale, Attitudes Toward Use, and subjective assessment of therapy comfort. [ Time Frame: 180 Days ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Auto Aflex
auto adjusting positive pressure therapy with AFLEX
Device: Auto AFlex
Positive pressure therapy treatment
Active Comparator: Auto CPAP
auto adjusting positive pressure therapy
Device: Auto CPAP
Positive pressure therapy treatment
Active Comparator: CPAP
continuous positive airway pressure
Device: CPAP
Positive pressure therapy treatment

Detailed Description:

Three arm randomized controlled trial evaluating therapy titration methodologies and device comfort.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 21 - 75
  • Diagnosis of OSAHS with baseline AHI equal or greater than 15 events/hr of sleep
  • Able and willing to provide written informed consent
  • Agreement to try PAP as initial treatment approach
  • Adequate clinical CPAP titration within two weeks of enrollment

Exclusion Criteria:

  • Participation in another interventional research study within the last 30 days
  • The need for more than one titration PSG
  • The use of sedatives or hypnotics during the titration PSG
  • Major medical or psychiatric condition that would interfere with the demands of the study, adherence to PAP, or the ability to commit to follow-up assessment.
  • Prior prescription for, or exposure to PAP therapy within the previous year (except exposure to CPAP during clinical therapy titration.)
  • Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe COPD or other pulmonary disorders, or any condition with an elevation of arterial carbon dioxide levels (>45 mmHG) while awake or participants qualifying for oxygen therapy (arterial saturation < or equal to 88% for more than five minutes).
  • Surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days
  • Surgery at any time for the treatment of OSAHS such as uvulopalatopharyngoplasty (UPPP)
  • Presence of untreated or poorly managed, non-OSAHS related sleep disorders:

    • moderate to severe periodic limb movements (greater or equal to 15 per hour with symptoms or arousals)
    • Restless Leg syndrome (greater than 10 per hour)
    • Males experiencing chronic insomnia
  • Use of medications with hypnotic or sedative effects or regular use of night time sedatives or sleeping aids greater than or equal to one night per week.
  • Consumption of ethanol more than 4 nights per week (CAGE criteria)
  • Shift workers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636181

Locations
United States, Alabama
Sleep Disorders Center of Alabama
Birmingham, Alabama, United States, 35213
United States, California
Stanford University
Stanford, California, United States, 94304
United States, Connecticut
Gaylord Hospital
New Haven, Connecticut, United States, 06472
United States, Florida
University of Florida
Gainesville, Florida, United States, 32608
Germany
Charite Universitatsmedizin Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Philips Respironics
Investigators
Principal Investigator: Clete A. Kushida, M.D.; Ph.D; Stanford University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clete Anthony Kushida, M.D., Ph.D, RPSGT, Stanford University
ClinicalTrials.gov Identifier: NCT00636181     History of Changes
Other Study ID Numbers: CTG3
Study First Received: February 6, 2008
Last Updated: June 9, 2009
Health Authority: United States: Institutional Review Board

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 October 19, 2014