Apnea Positive Pressure Long-Term Efficacy Study - Full Text View

Sponsored by:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00051363

Purpose

The purpose of this study is to determine the effectiveness of nasal continuous positive airway pressure (CPAP) therapy for the treatment of obstructive sleep apnea syndrome (OSAS).

Condition	Intervention	Phase
Lung Diseases Sleep Apnea Syndromes Sleep	Device: Positive Pressure Respiration Device: Sham CPAP machine	Phase III

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	APPLES: Apnea Positive Pressure Long-Term Efficacy Study

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

Effect of CPAP on neurocognitive function [ Time Frame: Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Attention and psychomotor (A/P) function [ Time Frame: Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention ] [ Designated as safety issue: No ]
Learning and memory (L/M) function [ Time Frame: Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention ] [ Designated as safety issue: No ]
Executive and frontal-lobe (E/F) function [ Time Frame: Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention ] [ Designated as safety issue: No ]
Sleepiness/Alertness [ Time Frame: Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention ] [ Designated as safety issue: No ]
Mood [ Time Frame: Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention ] [ Designated as safety issue: No ]
Quality of Life [ Time Frame: Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention ] [ Designated as safety issue: No ]

Enrollment:	1105
Study Start Date:	September 2002
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Active CPAP	Device: Positive Pressure Respiration Nightly nasal continuous positive airway pressure (CPAP)
2: Placebo Comparator Sham CPAP	Device: Sham CPAP machine Sham CPAP machine will be used for participants in the placebo group.

Detailed Description:

BACKGROUND:

Nasal CPAP therapy is in widespread use as the primary treatment for OSAS, a sleep-related breathing disorder affecting more than 15 million Americans. The therapeutic effectiveness of CPAP in providing significant, stable, and long-term neurocognitive or other functional benefits to patients with OSAS has not been systematically investigated.

DESIGN NARRATIVE:

The study is a randomized, blinded, sham-controlled, multi-center trial of CPAP therapy. The principal aims of the study are: 1) to assess the long-term effectiveness of CPAP therapy on neurocognitive function, mood, sleepiness, and quality of life by administering tests of these indices to subjects randomly assigned to active or sham CPAP; 2) to identify specific neurocognitive deficits associated with OSAS in a large, heterogeneous subject population; 3) to determine which deficits in neurocognitive function in OSAS subjects are reversible and most sensitive to the effects of CPAP; 4) to develop a composite multivariate outcome measure from the results of this study that can be used to assess the clinical effectiveness of CPAP in improving neurocognitive function, mood, sleepiness, and quality of life; and 5) to use functional magnetic resonance imaging to compare cortical activation before and after CPAP therapy, and to assess whether this change is associated with improvement in specific neurocognitive task performance. The primary endpoint of the study is the effect of six months of CPAP treatment on neurocognitive function. A total of 1100 subjects (550 per treatment group) will be enrolled from the patient populations at five sites (Stanford University; University of Arizona; Brigham and Women's Hospital; Massachusetts; St. Luke's Hospital, Missouri; St. Mary Medical Center, Washington).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female adults age 18 years or older with a diagnosis of OSAS using clinical criteria defined by the study protocol
Study participation may require seven or more laboratory visits over six months

Exclusion Criteria:

Prior treatment for OSAS with continuous positive airway pressure or surgery
Potential sleep apnea complications that may affect the health or safety of the participant, including low blood oxygen, recent near-miss or prior automobile accident due to sleepiness, congestive heart failure, history of angina, coronary artery disease, myocardial infarction or stroke, cardiac rhythm disturbance, and chronic neurological disorders affecting neurocognitive abilities or daily function
The use of hypnotics, anxiolytics, sedating antidepressants, anticonvulsants, sedating antihistamines, stimulants or other medications likely to affect neurocognitive function and/or alertness
Respiratory disease requiring medications (unless on stable medications for 2 months)
Cancer, unless in remission for greater than one year and not taking exclusionary medications
Self-reported renal failure
Pregnancy anytime during a subject's participation
Psychiatric illness, as defined by a DSM-IV diagnosis, except for depression or mild anxiety
Narcolepsy, idiopathic hypersomnolence, DSM-IV chronic insomnia, restless legs syndrome, or rapid eye movement (REM) behavior disorder
Current use of diurnal or nocturnal supplemental oxygen
Significant vision, hearing, or coordination problems
Difficulty understanding or speaking English
Currently working night or rotating shifts
Consumption of more than 10 caffeinated beverages per day (approximately 1,000 mg per day)
Smokers whose habit interferes with the overnight polysomnogram or with the battery of testing during the day
Consumption of more than 2 alcoholic beverages per day
Any illicit drug usage or marijuana usage more than once a week
Any individual in the household currently on CPAP or on CPAP in the past
A score of 26 or less on the Mini Mental State Examination (MMSE)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00051363

Locations

United States, Arizona
University of Arizona AHSC
Tucson, Arizona, United States, 85724
United States, California
Stanford University School of Medicine
Palo Alto, California, United States, 94305
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02459
United States, Missouri
St. Luke's Hospital
Chesterfield, Missouri, United States, 63017
United States, Washington
St. Mary Medical Center
Walla Walla, Washington, United States, 99362

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Study Chair:	William C. Dement, MD, PhD	Stanford University
Principal Investigator:	Clete A. Kushida, MD, PhD	Stanford University

More Information

Responsible Party:	Stanford University School of Medicine ( Clete A. Kushida, M.D., Ph.D., Principal Investigator )
Study ID Numbers:	150, U01 HL068060
Study First Received:	January 9, 2003
Last Updated:	August 29, 2008
ClinicalTrials.gov Identifier:	NCT00051363
Health Authority:	United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):

Obstructive Sleep Apnea

Study placed in the following topic categories:

Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Lung Diseases
Respiration Disorders

Sleep Apnea, Obstructive
Dyssomnias
Sleep Disorders
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome
Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009