Apnea Positive Pressure Long-Term Efficacy Study (APPLES)

Stanford University

Status and phase

Completed

Phase 3

Conditions

Sleep Apnea Syndromes

Lung Diseases

Sleep

Treatments

Device: Active CPAP

Device: Sham CPAP

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00051363

U01HL068060 (U.S. NIH Grant/Contract)

150

Details and patient eligibility

About

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).

Full 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).

Enrollment

1,105 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)