Positive Pressure Treatment of Obstructive Sleep Apnea

Not Applicable

Completed

Conditions: Obstructive Sleep Apnea

Interventions: Device: Auto AFlex
Device: Auto CPAP
Device: CPAP

Registration Number: NCT00636181

Lead Sponsor: Philips Respironics

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 168

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Auto Aflex	Auto AFlex	auto adjusting positive pressure therapy with AFLEX
Auto CPAP	Auto CPAP	auto adjusting positive pressure therapy
CPAP	CPAP	continuous positive airway pressure

Primary Outcome Measures

Name	Time	Method
Apnea-Hypopnea Index	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

Name	Time	Method
Average Hours of Nightly Use.	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.
Psychomotor Vigilance Task - Number of Lapses	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.
Functional Outcomes of Sleep Questionnaire (FOSQ)	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.
Attitudes Toward Use	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.
Subjective Assessment of Therapy Comfort.	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
Epworth Sleepiness Scale	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.

Trial Locations

Locations (5): Gaylord Hospital
🇺🇸
New Haven, Connecticut, United States
Sleep Disorders Center of Alabama
🇺🇸
Birmingham, Alabama, United States
Charite Universitatsmedizin Berlin
🇩🇪
Berlin, Germany
University of Florida
🇺🇸
Gainesville, Florida, United States
Stanford University
🇺🇸
Stanford, California, United States