Positive Pressure Treatment of Obstructive Sleep Apnea

NCT00636181 | Completed Results

• 1 other identifier: CTG3
• Study Type: interventional
• Target: 168
• Locations: 2 countries
• Sites: 5

Brief Summary

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

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Average Hours of Nightly Use.

  180 days

• Psychomotor Vigilance Task - Number of Lapses

  Baseline and 180 Days

• Functional Outcomes of Sleep Questionnaire (FOSQ)

  Baseline and 180 Days

• Attitudes Toward Use

  Baseline and 180 Days

• Subjective Assessment of Therapy Comfort.

  30, 90, and 180 days

Study Arms (3)

Auto Aflex

ACTIVE COMPARATOR

auto adjusting positive pressure therapy with AFLEX

Device: Auto AFlex

Auto CPAP

ACTIVE COMPARATOR

auto adjusting positive pressure therapy

Device: Auto CPAP

CPAP

ACTIVE COMPARATOR

continuous positive airway pressure

Device: CPAP

Interventions

Auto AFlex DEVICE

Positive pressure therapy treatment

Auto Aflex

Auto CPAP DEVICE

Positive pressure therapy treatment

Auto CPAP

CPAP DEVICE

Positive pressure therapy treatment

CPAP

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philips Respironics: lead

Study Sites (5)

Sleep Disorders Center of Alabama

Birmingham, Alabama, 35213, United States

Location

Stanford University

Stanford, California, 94304, United States

Location

Gaylord Hospital

New Haven, Connecticut, 06472, United States

Location

University of Florida

Gainesville, Florida, 32608, United States

Location

Charite Universitatsmedizin Berlin

Berlin, 10117, Germany

Location

Related Publications (2)

• 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.

  PMID: 15947324 BACKGROUND

• 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.

  PMID: 21804670 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clete A. Kushida, MD, PhD
• Organization: Stanford Sleep Medicine Center

clete@stanford.edu

(650) 721-7560

Study Officials

• Clete A. Kushida, M.D.; Ph.D;

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 6, 2008
• First Posted: March 14, 2008
• Study Start: January 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: August 13, 2019
• Results First Posted: August 13, 2019

Record last verified: 2019-07

Locations

US (4); DE (1)