Submission date
06/01/2006
Registration date
10/07/2006
Last edited
14/04/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Retrospectively registered
? Protocol not yet added
? SAP not yet added
? Results not yet added and study completed for more than 1 year
? Raw data not yet added
Study completed

Plain English Summary

Not provided at time of registration

Study website

Contact information

Type

Scientific

Contact name

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/CTIS number

IRAS 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(s)

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

Study setting(s)

Not specified

Study 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

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

Overall study end date

07/01/2006

Reason abandoned (if study stopped)

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(s)

Patient

Age group

Adult

Lower age limit

18 Years

Upper age limit

64 Years

Sex

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

Study 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

ROR

https://ror.org/03njmea73

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

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?

Additional files

Editorial Notes