The Apnea Positive Pressure Long-term Efficacy Study (APPLES): rationale, design, methods, and procedures.
OBJECTIVE
To assess the size, time course, and durability of the effects of long-term continuous positive airway pressure (CPAP) therapy on neurocognitive function, mood, sleepiness, and quality of life in patients with obstructive sleep apnea.


METHODS
Randomized, double-blinded, 2-arm, sham-controlled, multicenter, long-term, intention-to-treat trial of CPAP therapy.


METHODS
Sleep clinics and laboratories at 5 university medical centers and community-based hospitals.


METHODS
Target enrollment is 1100 randomly assigned subjects across 5 clinical centers.


METHODS
Active versus sham (subtherapeutic) CPAP.


RESULTS
A battery of conventional and novel tests designed to evaluate neurocognitive function, mood, sleepiness, and quality of life.


CONCLUSIONS
The Apnea Positive Pressure Long-term Efficacy Study (APPLES) is designed to study obstructive sleep apnea and test the effects of CPAP through a comprehensive, controlled, and long-term trial in a large sample of subjects with obstructive sleep apnea.
Kushida
Clete A
CA
Stanford Universit)y, Stanfbrd, CA, USA. clete@stanford.edu
Nichols
Deborah A
DA
Quan
Stuart F
SF
Goodwin
James L
JL
White
David P
DP
Gottlieb
Daniel J
DJ
Walsh
James K
JK
Schweitzer
Paula K
PK
Guilleminault
Christian
C
Simon
Richard D
RD
Leary
Eileen B
EB
Hyde
Pamela R
PR
Holmes
Tyson H
TH
Bloch
Daniel A
DA
Green
Sylvan
S
McEvoy
Linda K
LK
Gevins
Alan
A
Dement
William C
WC
D045422:Continuous Positive Airway Pressure / Q000379:methods*; D004311:Double-Blind Method; D020408:Health Insurance Portability and Accountability Act; D006801:Humans; D017286:Polysomnography; D011786:Quality Control; D011788:Quality of Life / Q000523:psychology; D020181:Sleep Apnea, Obstructive / Q000175:diagnosis* / Q000628:therapy*; D016896:Treatment Outcome; D014481:United States