Self-report and physiological measures of sleep quality

ISRCTN	ISRCTN77616219
DOI	https://doi.org/10.1186/ISRCTN77616219
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Andrew Krystal
Scientific

Duke University Medical Center
Box 3309
Durham, NC
27710
United States of America

Email	kryst001@mc.duke.edu

Study design	Randomised comparison of ratings of sleep in subjects led to the belief that they had good versus bad nights of sleep
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	Self-report sleep ratings reflect the formation of a global impression that colors all of the ratings.
Ethics approval(s)	Ethics approval details not yet received as of 24/05/2006
Health condition(s) or problem(s) studied	Sleep quality
Intervention	Patients were asked to score their sleep rating after being led to believe that they had either: 1. A bad nights sleep, or 2. A good nights sleep Comparisons were run between the actual sleep activity and the percieved sleep activity.
Intervention type	Other
Primary outcome measure	A single morning self-rating of: 1. Sleep latency 2. Time awake in the middle of the night 3. Total sleep time
Secondary outcome measures	1. Relationship of polysomnographic and self-reported measures of sleep latency 2. Time awake in the middle of the night 3. Total sleep time
Overall study start date	09/01/2005
Completion date	07/01/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	64 Years
Sex	Both
Target number of participants	20
Key inclusion criteria	1. Aged 18 - 64 years inclusive 2. Able to understand and cooperate with study procedures and give informed consent
Key exclusion criteria	1. Any symptom of daytime sleepiness 2. Any difficulty falling asleep or staying asleep in the last month 3. Any active medical or psychiatric disease that is likely to affect sleep 4. Taking any medication that might affect sleep within five half-lives of screening
Date of first enrolment	09/01/2005
Date of final enrolment	07/01/2006

Duke University Medical Center

Durham, NC
27710
United States of America

Duke University Medical Center (USA)
University/education

Box 3309
Durham, NC
27710
United States of America

University/education

Duke University Department of Psychiatry (USA)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan