Condition category
Nervous System Diseases
Date applied
06/01/2006
Date assigned
10/07/2006
Last edited
14/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew Krystal

ORCID ID

Contact details

Duke University Medical Center
Box 3309
Durham
NC
27710
United States of America
kryst001@mc.duke.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Self-report sleep ratings reflect the formation of a global impression that colors all of the ratings.

Ethics approval

Ethics approval details not yet received as of 24/05/2006

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

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

09/01/2005

Overall trial end date

07/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 - 64 years inclusive
2. Able to understand and cooperate with study procedures and give informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant 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

Recruitment start date

09/01/2005

Recruitment end date

07/01/2006

Locations

Countries of recruitment

United States of America

Trial participating centre

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

Sponsor information

Organisation

Duke University Medical Center (USA)

Sponsor details

Box 3309
Durham
NC
27710
United States of America
+1 919 681 8788
kryst001@mc.duke.edu

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Duke University Department of Psychiatry (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes