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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04752254
Other study ID # 7987
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date August 31, 2023

Study information

Verified date August 2023
Source University Hospital, Strasbourg, France
Contact Patrice BOURGIN, MD, PhD
Phone 33 3 88 11 64 30
Email patrice.bourgin@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Cognitive arousal has been identified as playing a key role in the inability to fall asleep or stay asleep. However, although people with insomnia frequently complain about racing thoughts appearing as soon as they get into bed, studies focusing on racing thoughts in insomnia are lacking. The aim of the present study is to investigate racing thoughts in insomnia disorder using a self-report questionnaire, the Racing and Crowded Thoughts Questionnaire. Specifically, the researchers seek to address three related goals: the comparison of RCTQ scores in adults with primary insomnia, healthy individuals, and patients with bipolar disorder in a manic/hypomanic episode; the variation of RCTQ scores relative to time of day; and the specific contribution of racing thoughts to insomnia severity, as compared to worry and rumination.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date August 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 78 Years
Eligibility Inclusion Criteria: - Major subject from 18 to 70 years old) - with a diagnosis of chronic primary insomnia according to the criteria of ICSD-3 - Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research Exclusion Criteria: - Subject having expressed opposition to participating in the study - Subject under guardianship or guardianship - Subject under safeguard of justice - Patient with secondary insomnia (OSA, circadian rhythm disorder, severe restless legs syndrome, bipolar disorder, ADD +/- H) - Subject under psychotropic treatment other than hypnotics - Incomplete data concerning the main endpoint

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Center for Sleep Disorders - CIRCSom - Strasbourg University Hospitals Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary A retrospective evaluation of self-reported tachypsychia in primary insomnia Files analysed retrospectively from Jun 01, 2014 to March 13, 2020 will be examined]
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