Insomnia DisorderTIPNCT04752254
Investigating Racing Thoughts in Patients With Insomnia Disorder
An observational study of Insomnia Disorder, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Insomnia Disorder
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2020to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- All sexes
- Adult, Older adult
Study population: Major subject with a diagnosis of chronic primary insomnia according to the criteria of ICSD-3
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Center for Sleep Disorders - CIRCSom - Strasbourg University Hospitals
Strasbourg, 67091
Patrice BOURGIN, MD, PhD, 33 3 88 11 64 30, patrice.bourgin@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, 33 3 88 11 66 90, said.chayer@chru-strasbourg.fr
About this study
Official title: Cognitive Hyperarousal in Insomnia Disorder
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.
- Conditions
- Insomnia Disorder
- Keywords
- Insomnia, Hyperarousal, Rumination, Racing thoughts
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Rumination Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
A retrospective evaluation of self-reported tachypsychia in primary insomnia
Measured: Files analysed retrospectively from Jun 01, 2014 to March 13, 2020 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start1 Oct 2020
- Primary completion31 Aug 2023
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insomnia DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752254
- Sponsor's protocol ID
- 7987
- Acronym
- TIP
- Status last verified
- Aug 2023
- First submitted
- 8 Feb 2021
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Weiner L, Martz E, Kilic-Huck U, Siegel N, Bertschy G, Geoffroy PA, Weibel S, Bourgin P. Investigating racing thoughts in insomnia: A neglected piece of the mood-sleep puzzle? Compr Psychiatry. 2021 Nov;111:152271. doi: 10.1016/j.comppsych.2021.152271. Epub 2021 Sep 17.
PubMed 34555554
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Hyperarousal in Insomnia Disorder
- ClinicalTrials.gov ID
- NCT04752254
- Acronym / sponsor ID
- TIP / 7987
- Conditions
- Insomnia Disorder
- Keywords
- Insomnia, Hyperarousal, Rumination, Racing thoughts
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Major subject with a diagnosis of chronic primary insomnia according to the criteria of ICSD-3
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A retrospective evaluation of self-reported tachypsychia in primary insomnia
Time frame: Files analysed retrospectively from Jun 01, 2014 to March 13, 2020 will be examined]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Derived from this study: PubMed 34555554Weiner L, Martz E, Kilic-Huck U, Siegel N, Bertschy G, Geoffroy PA, Weibel S, Bourgin P. Investigating racing thoughts in insomnia: A neglected piece of the mood-sleep puzzle? Compr Psychiatry. 2021 Nov;111:152271. doi: 10.1016/j.comppsych.2021.152271. Epub 2021 Sep 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insomnia Disorder, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrice BOURGIN, MD, PhD (33 3 88 11 64 30, patrice.bourgin@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A retrospective evaluation of self-reported tachypsychia in primary insomnia (time frame: Files analysed retrospectively from Jun 01, 2014 to March 13, 2020 will be examined]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04752254, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.