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Positive Pressure Treatment of Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT00636181
Recruitment Status : Completed
First Posted : March 14, 2008
Results First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Clete Kushida, Stanford University

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

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Auto AFlex Device: Auto CPAP Device: CPAP Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Positive Airway Pressure Initiation: Impact of Therapy Mode and Titration Process on Adherence and Outcomes
Study Start Date : January 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Apnea-Hypopnea Index [ Time Frame: Baseline and 180 Days ]
    The Apnea-Hyopnea Index is the number of average number of apneas (complete pauses in breathing lasting at least 10 seconds) and hypopneas (decreases in airflow lasting at least 10 seconds) per hour of sleep. This data was compared from the polysomnography (sleep study) data after the first night of device use and at 180 days


Secondary Outcome Measures :
  1. Average Hours of Nightly Use. [ Time Frame: 180 days ]
    The average hours of nightly use is the average number of hours the participant used there device overnight at home during the study.

  2. Psychomotor Vigilance Task - Number of Lapses [ Time Frame: Baseline and 180 Days ]

    Psychomotor Vigilance Task-PVT is a 10-min attention/vigilance test. To measure trends of vigilance after 180 days of home use randomized sleep apnea trial. This measured how quickly participants reacted to visual stimulus and counted number of lapses.

    Lapses (errors of omission) are measured or usually defined as reaction Times ≥ 500 ms.


  3. Functional Outcomes of Sleep Questionnaire (FOSQ) [ Time Frame: Baseline and 180 Days ]

    FOSQ is a quality of life questionnaire for sleep disorders. It's a 30 question survey with 5 subgroups: general productivity (8 questions), social outcome (2 questions),activity level (9 questions), vigilance (7 questions) and intimate relationships & sexual activity (4 questions).

    Scores are provided on a 0 to 4 scale:

    0- I don't do this activity for other reasons or missing response

    1- Yes, extreme difficulty 4- no difficulty

    The average score was calculated based upon average sub-scores. The total score was,calculated using the mean of the subscale scores and multiplying the mean by the number of subscales. The range of scores for the total score is 5-20. The measures are designed to assess the impact of disorders of excessive sleepiness on activities of everyday living and the extent to which these abilities are improved by effective treatment. The lower the score the more difficulty a person has carrying out certain activities because they are too sleepy or tired.


  4. Attitudes Toward Use [ Time Frame: Baseline and 180 Days ]

    Attitudes Toward Use Questionnaire (ATUQ) a self-efficacy scale based on psychological theories of behavior change and modified from one developed by Stepnowsky and Marler this outcome focused on confidence, expectations and importance.

    Confidence is a 5 question survey, it is measured on a scale of 1 to 5 1- disagree completely and 5 being agree completely. The scores range from 5 to 25 with 25 being extremely confident.

    Importance is a 11 question survey, it is measured on a scale of 1 to 5 1- disagree completely and 5 being agree completely. The importance ATU was combined with Exceptions survey, which is 4 questions. The expectations survey is measured on a scale of 1 to 5, with 1 being not at all effective and 5 extremely effective. The scores range from 15 to 75 with 75 being extremely important/ extremely effective.


  5. Subjective Assessment of Therapy Comfort. [ Time Frame: 30, 90, and 180 days ]

    visual analog scales where used to assess the question "in the last month how do you rate the overall comfort of the mask"?

    0 = very uncomfortable to 100 = very comfortable


  6. Epworth Sleepiness Scale [ Time Frame: Baseline and 180 days ]

    Epworth Sleepiness Scale is a test that measures sleepiness during daily life activities. This is an 8 question survey.

    Scores are provided on a 0 to 3 scale:

    0 = no chance of dozing

    1. = slight chance of dozing
    2. = moderate chance of dozing
    3. = high chance of dozing

    Scores range from 0 to 24. The higher the total number, the higher the overall sleepiness.




Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 21 - 75
  • Diagnosis of OSAHS with baseline AHI (Apnea-Hypopnea Index) equal or greater than 15 events/hr of sleep
  • Able and willing to provide written informed consent
  • Agreement to try PAP (positive airway pressure) 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 (polysomnography)
  • 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 (chronic obstructive pulmonary disease) 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

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): NCT00636181


Locations
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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
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Principal Investigator: Clete A. Kushida, M.D.; Ph.D; Stanford University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Clete Kushida, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00636181     History of Changes
Other Study ID Numbers: CTG3
First Posted: March 14, 2008    Key Record Dates
Results First Posted: August 13, 2019
Last Update Posted: August 13, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases