Investigating Racing Thoughts in Patients With Insomnia Disorder

Insomnia Disorder Clinical Trial

— TIP  

Official title:

Cognitive Hyperarousal in Insomnia Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04752254
• Other study ID #: 7987
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Insomnia Disorder
• Sleep Initiation and Maintenance Disorders

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]