Clinical trial NCT00636181: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Philips Respironics
Sponsor class: INDUSTRY
First posted: 2008-03-14
Enrollment: 168
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Apnea-Hypopnea Index
timeFrame: Baseline and 180 Days
Secondary outcomes:
measure: Average Hours of Nightly Use.
timeFrame: 180 days
measure: Psychomotor Vigilance Task - Number of Lapses
timeFrame: Baseline and 180 Days
measure: Functional Outcomes of Sleep Questionnaire (FOSQ)
timeFrame: Baseline and 180 Days
measure: Attitudes Toward Use
timeFrame: Baseline and 180 Days
measure: Subjective Assessment of Therapy Comfort.
timeFrame: 30, 90, and 180 days
measure: Epworth Sleepiness Scale
timeFrame: Baseline and 180 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sleep Disorders Center of Alabama
state: Alabama
city: Stanford
country: United States
facility: Stanford University
state: California
city: New Haven
country: United States
facility: Gaylord Hospital
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Berlin
country: Germany
facility: Charite Universitatsmedizin Berlin
Study officials:
affiliation: Stanford University
name: Clete A. Kushida, M.D.; Ph.D;
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.