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Positive Pressure Treatment of Obstructive Sleep Apnea

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Auto AFlex
Auto CPAP
CPAP
Sponsored by
Philips Respironics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sleep Disorders Center of Alabama
  • Stanford University
  • Gaylord Hospital
  • University of Florida
  • Charite Universitatsmedizin Berlin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Auto Aflex

Auto CPAP

CPAP

Arm Description

auto adjusting positive pressure therapy with AFLEX

auto adjusting positive pressure therapy

continuous positive airway pressure

Outcomes

Primary Outcome Measures

Apnea-Hypopnea Index
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

Average Hours of Nightly Use.
The average hours of nightly use is the average number of hours the participant used there device overnight at home during the study.
Psychomotor Vigilance Task - Number of Lapses
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.
Functional Outcomes of Sleep Questionnaire (FOSQ)
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.
Attitudes Toward Use
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.
Subjective Assessment of Therapy Comfort.
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
Epworth Sleepiness Scale
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 = slight chance of dozing = moderate chance of dozing = high chance of dozing Scores range from 0 to 24. The higher the total number, the higher the overall sleepiness.

Full Information

First Posted
February 6, 2008
Last Updated
July 25, 2019
Sponsor
Philips Respironics
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1. Study Identification

Unique Protocol Identification Number
NCT00636181
Brief Title
Positive Pressure Treatment of Obstructive Sleep Apnea
Official Title
Positive Airway Pressure Initiation: Impact of Therapy Mode and Titration Process on Adherence and Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Philips Respironics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Six month at home positive pressure therapy study; which mode of therapy will lead to better adherence and patient outcomes?
Detailed Description
Three arm randomized controlled trial evaluating therapy titration methodologies and device comfort.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Auto Aflex
Arm Type
Active Comparator
Arm Description
auto adjusting positive pressure therapy with AFLEX
Arm Title
Auto CPAP
Arm Type
Active Comparator
Arm Description
auto adjusting positive pressure therapy
Arm Title
CPAP
Arm Type
Active Comparator
Arm Description
continuous positive airway pressure
Intervention Type
Device
Intervention Name(s)
Auto AFlex
Intervention Description
Positive pressure therapy treatment
Intervention Type
Device
Intervention Name(s)
Auto CPAP
Intervention Description
Positive pressure therapy treatment
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
Positive pressure therapy treatment
Primary Outcome Measure Information:
Title
Apnea-Hypopnea Index
Description
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
Time Frame
Baseline and 180 Days
Secondary Outcome Measure Information:
Title
Average Hours of Nightly Use.
Description
The average hours of nightly use is the average number of hours the participant used there device overnight at home during the study.
Time Frame
180 days
Title
Psychomotor Vigilance Task - Number of Lapses
Description
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.
Time Frame
Baseline and 180 Days
Title
Functional Outcomes of Sleep Questionnaire (FOSQ)
Description
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.
Time Frame
Baseline and 180 Days
Title
Attitudes Toward Use
Description
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.
Time Frame
Baseline and 180 Days
Title
Subjective Assessment of Therapy Comfort.
Description
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
Time Frame
30, 90, and 180 days
Title
Epworth Sleepiness Scale
Description
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 = slight chance of dozing = moderate chance of dozing = high chance of dozing Scores range from 0 to 24. The higher the total number, the higher the overall sleepiness.
Time Frame
Baseline and 180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clete A. Kushida, M.D.; Ph.D;
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep Disorders Center of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Gaylord Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06472
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Charite Universitatsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
15947324
Citation
Aloia MS, Stanchina M, Arnedt JT, Malhotra A, Millman RP. Treatment adherence and outcomes in flexible vs standard continuous positive airway pressure therapy. Chest. 2005 Jun;127(6):2085-93. doi: 10.1378/chest.127.6.2085.
Results Reference
background
PubMed Identifier
21804670
Citation
Kushida CA, Berry RB, Blau A, Crabtree T, Fietze I, Kryger MH, Kuna ST, Pegram GV Jr, Penzel T. Positive airway pressure initiation: a randomized controlled trial to assess the impact of therapy mode and titration process on efficacy, adherence, and outcomes. Sleep. 2011 Aug 1;34(8):1083-92. doi: 10.5665/SLEEP.1166.
Results Reference
derived

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Positive Pressure Treatment of Obstructive Sleep Apnea

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