SLEEP 2011 Abstract Supplement

B. Clinical Sleep Science XIV. Instrumentation and Methodology
Support (If Any): This work was conducted with support from National
Institutes of Health Grant RO1 HL074972-01 and a KL2 Medical Research
Investigator Training (MeRIT) grant awarded via Harvard Catalyst
/ The Harvard Clinical and Translational Science Center (NIH grant
#1KL2RR025757-01 and financial contributions from Harvard University
and its affiliated academic health care centers).
0958
COMPARISON OF COMMONLY USED VISUAL ANALOGUE
SCALE FORMATS FOR ASSESSING CHANGE IN SLEEP
QUALITY
Keenan EK, Rogers PJ
Experimental Psychology, University of Bristol, Bristol, United
Kingdom
Introduction: There is no consistent way of assessing sleep quality. It
can be estimated from measured variables such as sleep efficiency, from
a composite measure such as the LSEQ or rated in its own right. The
LSEQ has the advantage of negating the need for a baseline week, as it
requires participants to rate their own change from baseline.
Methods: Fifty-four poor sleepers took part in a 3-week placebo controlled
dietary intervention study that included a baseline week. Sleep
diaries included ratings in different formats; ‘How would you rate the
quality of your sleep last night?’ and ‘How would you rate the quality
of your sleep last night after using the supplement compared with your
usual sleep without the supplement?’ (more restless/restful, awake more/
less than usual). Paired t-tests and correlations were made between the
different question formats averaged over each week.
Results: There was no significant difference between the single rating
and the LSEQ composite measure of sleep quality, and correlations
were significant at .63 and .73 in week 1 and week 2 respectively. However,
when change scores were calculated (week one minus baseline)
and compared with the LSEQ composite measure, significant differences
were found at week one (p < .03) and correlations were somewhat
weaker (r = .54 and .63 respectively). For a more direct comparison of
format, analyses were also performed on single ratings of ‘refreshed’
and although well correlated (r = .51 and .75), scores were significantly
different (p < .003).
Conclusion: It is suggested that the use of a baseline week would be
more suitable for assessing change when participants’ baseline sleep is
highly variable, as is often the case in those with poor sleep. Participants
with poor sleep are likely to find the task of making comparisons to ‘usual’
sleep difficult as they have more variable sleep than good sleepers.
0959
A WEB-BASED MORNING SLEEP DIARY SYSTEM
DeBrota D, Burgess J, Hong Q, Larkin A
Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN,
USA
Introduction: Widespread availability of and familiarity with computers
and web browsers has enabled collection of data directly from outpatients
participating in clinical trials. We describe an interactive, graphical
morning sleep diary system with which patients interacted on a daily
basis for several weeks in the multicenter Phase 2 clinical trial I2K-MC-
ZZAD(b).
Methods: Multiple exemplars of sleep diaries used in past studies were
reviewed, and data elements to be collected were chosen. An interactive
display of a noon-to-noon timeline was developed, such that as a
patient would report on his/her times of study drug ingestion, lights off,
sleep onset, final awakening, lights on, alarm set time, and nap start/stop
times, the timeline would dynamically update a graphical representation
of these events and of when and for how long at time the patient
was asleep. Unusual values provided were immediately challenged. Patients
indicated their overall sleep quality on a visual analog scale, and
answered a Yes/No question, “Did you sleep well last night?” Patients
also answered multiple choice questions about their difficulty getting to
sleep and returning to sleep after awakenings, their sleep experience, and
their feeling upon awakening. Patients were provided with laptops with
built-in wireless wide area network connectivity which automatically
launched a web browser and connected to the study’s web server when
powered on, to minimize difficulty for patients with little computer experience.
All entries were timestamped.
Results: Compliance with morning diaries was very high. Diary entries
were completed quickly by patients, and there was very little missing
data. System downtime was minimal. Patients questioned about the
morning diary system indicated a high level of comfort and satisfaction
with it.
Conclusion: Daily, contemporaneous collection directly from patients
of high quality and highly detailed information about sleep was successfully
accomplished by a web-based system.
0960
VALIDATION OF AN EXCESSIVE SLEEPINESS DIARY (ESD)
Norquist J 1 , Liao J 1 , Dinges DF 2 , Roth T 3 , Herring WJ 1 , Brodovicz K 1
1
Merck Sharpe & Dohme, North Wales, PA, USA, 2 University of
Pennsylvania, Philadelphia, PA, USA, 3 Henry Ford Hospital, Detroit,
MI, USA
Introduction: Excessive Sleepiness (ES) is a symptom associated with
sleep disorders (e.g. narcolepsy, obstructive sleep apnea), non-sleep disorders
(e.g., multiple sclerosis, cancer, depression), and certain occupations.
The aim of this study was to characterize measurement properties
of a newly developed daily diary designed to assess sleepiness and its
impact among patients experiencing ES.
Methods: The Excessive Sleepiness Diary (ESD) is a 16-question, paper-and-pencil
self-administered daily diary completed in the evening
before going to bed. The ESD assesses experiences related to sleepiness
including difficulty staying awake, difficulty concentrating, feeling
tired or sleepy, taking naps, and motor vehicle or other accidents or
near-accidents. The ESD also collects information on factors that may
impact ES, including consumption of caffeinated and alcoholic beverages
and cigarettes. The ESD was included in a randomized, doubleblind,
double-dummy, placebo and active controlled (modafinil 200
mg), 3-period crossover study with 2-week treatment periods to treat ES
in patients with obstructive sleep apnea/hypopnea syndrome (OSA/HS),
appropriately using nCPAP therapy. Improvement on the Maintenance
of Wakefulness Test (MWT) was the primary efficacy endpoint. The Epworth
Sleepiness Scale (ESS), SF36, Clinical Global Impression scales
(CGI), and Functional Outcomes of Sleep Questionnaire (FOSQ) were
included. The data from this study were used to assess the psychometric
properties of the ESD.
Results: 125 patients were enrolled. Factor analysis of the ESD items
supported combining the items into a total ES score. Test-retest reliability
(ICC) coefficients of the single items and total score ranged from 0.4
to 0.7. Cross-sectional and longitudinal construct validity of the ESD
was supported by moderate correlations (r > 0.5) with other measures
included in the study. The ESD was able to distinguish severity groups
by level of ES as measured by ESS and CGI (p