Positive Pressure Treatment of Obstructive Sleep Apnea

Positive Airway Pressure Initiation: Impact of Therapy Mode and Titration Process on Adherence and Outcomes

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

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Auto AFlex; Device: Auto CPAP; Device: CPAP

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charite Universitatsmedizin Berlin
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35213
      • Sleep Disorders Center of Alabama
  • California
    • Stanford, California, United States, 94304
      • Stanford University
  • Connecticut
    • New Haven, Connecticut, United States, 06472
      • Gaylord Hospital
  • Florida
    • Gainesville, Florida, United States, 32608
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline and 180 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	180 days
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.	Baseline and 180 Days
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.	Baseline and 180 Days
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.	Baseline and 180 Days
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	30, 90, and 180 days
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.	Baseline and 180 days

Collaborators and Investigators

• Sponsor: Philips Respironics
• Investigators: Principal Investigator: Clete A. Kushida, M.D.; Ph.D;, Stanford University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: February 6, 2008
• First Submitted That Met QC Criteria: March 13, 2008
• First Posted (Estimate): March 14, 2008

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: July 25, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: CTG3