Polysomnogram Recordings at Clinical Sites
Policies and Procedures
The policies and procedures that will be used to obtain the polysomnogram recordings
in this clinical trial “Weight Loss and Sleep Apnea in Look AHEAD Participants”
(Sleep AHEAD) are taken directly from those detailed in the Polysomnogram Reading
Center Manual of Operations developed for the Sleep Heart Health Study (1,2).
The policies and procedures in the Sleep Heart Health Study were developed to
obtain consistent (reliable), objective data in a large number of individuals
studied with the same equipment in unattended settings for the purposes of developing
a large and versatile research database (1,2). The Sleep Heart Health Study
manual established the “gold standard” for the policies and procedures
needed to perform sleep evaluations in multi-site clinical trials. Although
the size of the current study is smaller that the Sleep Heart Health Study,
the same challenges are faced in the proposed trial concerning the ability to
uniformly collect data at different sites, transmit the data to a core laboratory,
and analyze the data for the Data Coordinating Center. Large sections of the
Sleep Heart Health Study manual have been reproduced in the current manual.
Changes made from the Sleep Heart Health Study manual reflect differences in
study design and implementation.