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Completed

NCT Number: NCT00636181

Positive Pressure Treatment of Obstructive Sleep Apnea

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

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charite Universitatsmedizin Berlin, Berlin, Germany

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auto AFlex

Device

Positive pressure therapy treatment

Auto CPAP

Device

Positive pressure therapy treatment

CPAP

Device

Positive pressure therapy treatment

Primary outcomes

  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 outcomes

  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

    • = 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.

Sponsors and collaborators

Lead sponsor

Philips Respironics

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 14, 2008
Registry last updated
Aug 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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