InsomniaSOMNETNCT02821234
The Sleepless Brain: Neuroimaging Support for a Differential Diagnosis of Insomnia
A study testing MRI in people with Insomnia, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
One-tenth of the population suffers from insomnia, increasing their risk on other health problems such as depression. Self-reported sleep quality only was historically leading for insomnia diagnosis, but more recently a state of 24-hour hyperarousal has been associated with insomnia, either physiological (increased… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2016to 3 Apr 2017
- Phase
- Interventional
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Insomnia group: patients with insomnia: sleep complaints, of at least 3 nights a week, for at least 3 months, affected daytime functioning.
- control group: no self-reported sleep problems in the last 2 months.
- 20-50 years old.
- Male or female.
- having given written informed consent to participate in the research project.
Who cannot join
- Night and shift-workers.
- Psychiatric disorder: clinical mood disorder, anxiety disorder, psychosis, bipolar disorder.
- For insomnia group: all sleep disorders other than persistent insomnia.
- For control group: all sleep disorders.
- Progressive neurological diseases that include restless legs syndrome.
- Cardiovascular disease other than treated hypertension.
Show all 14Show fewer
- Unstable respiratory or endocrinological diseases.
- Drug addiction, alcohol addiction during the previous 6 months.
- Having undertaken trans-meridian travel (± 3H) in the previous 1 month.
- Pregnant or lactating women.
- Chronic pain.
- Hypnotic and psychotropic medication taking or stopped less than 5 half-life periods of molecules before screening V0.
- Patient participating to any other interventional study.
- For MRI: presence of a ferromagnetic foreign body (in particular certain intracranial clips, certain cardiac valves, intraocular foreign body, or subject having worked with metals), the presence of an implanted pacemaker, subject with cardiac or brain valves of ventricular derivation (risk of maladjustment), claustrophobia.
Trial locations and contacts
1 site in 1 country.
About this study
One-tenth of the population suffers from insomnia, increasing their risk on other health problems such as depression. Self-reported sleep quality only was historically leading for insomnia diagnosis, but more recently a state of 24-hour hyperarousal has been associated with insomnia, either physiological (increased heart rate, higher frequency EEG) or predominant cognitive-emotional hyperarousal (worry, rumination, repetitive thoughts). Strong evidence shows that those suffering from insomnia with physiological hyperarousal are at higher risk of short and long term severe health problems such as inflammation and hypertension than the group without physiological hyperarousal. The neurophysiological basis of these insomnia phenotypes has however barely been investigated, although its results can have major consequences for how this limiting condition will be treated.
To support the development of a differential diagnosis of insomnia, structural and functional brain connectivity in insomnia patients with different levels of hyperarousal will be investigated and related to sleep variables. Investigators will compare the insomnia group to a normal sleeping control group. Investigators expect that the emotion processing circuit (amygdala-ventromedial prefrontal cortex) is a) more affected in insomniacs compared to normal sleeping controls and b) the directionality of this effect to depend on the level and type of hyperarousal in insomniacs. Further, investigators expect c) amygdala activity to be positive correlated with physiological hyperarousal level and d) prefrontal activity to be positively correlated with cognitive-emotional hyperarousal level. Investigators expect a higher physiological hyperarousal level to be reflected in affected afferent pathways of the amygdala towards the ventromedial prefrontal cortex and investigators expect higher cognitive-emotional hyperarousal to be related to affected efferent pathways from the ventromedial prefrontal cortex to the amygdala. Investigators expect sleep quality to play a mediating role in both types of hyperarousal and their brain activation patterns in insomnia patients and normal sleeping controls.
These data can lead to the definition of new insomnia phenotypes and to new customized and effective insomnia treatment, focused not only on improving sleep but also on changing dysfunctional hyperarousal levels that currently put insomniacs at risk of numerous severe health problems.
- Conditions
- Insomnia
- Being tested
- MRI
- Keywords
- Insomnia, Hyperarousal
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
| Study group | Role | What they receive |
|---|---|---|
| Insomnia group | Experimental | Patients with insomnia: sleep complaints, of at least 3 nights a week, for at least 3 months, affected daytime functioning, objectified low sleep quality (SE <85%) with 10 days actigraphy occurred in the last 2 months Receives: Other: MRI |
| Control group | Experimental | Volunteer without sleep problems either self-reported or objectified through actigraphy (SE ≥85%) Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting state intrinsic connectivity within the emotion processing network by MRI
Measured: During Visit V2 (study termination), up to 3 month after consent signature
Secondary outcomes (16)
Total sleep time obtained by actimetry
Measured: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
Sleep efficiency obtained by actimetry
Measured: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
Wake after sleep onset obtained by actimetry
Measured: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
Sleep latency obtained by actimetry
Measured: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
Total sleep time obtained by sleep diary
Measured: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
Sleep efficiency obtained by sleep diary
Measured: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
Wake after sleep onset obtained by sleep diary
Measured: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
sleep latency obtained by sleep diary
Measured: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
Questionnaire regarding sleep problems : Pittsburgh Sleep Questionaire (PSQ)
Measured: During Pre-inclusion Visit, at consent signature
Questionnaire regarding sleep problems : Insomnia Severity Index (ISI)
Measured: During Pre-inclusion Visit, at consent signature
Questionnaire regarding depression : Beck Depression Inventory (BDI)
Measured: During Pre-inclusion Visit, at consent signature
Questionnaire regarding anxiety : Beck Anxiety Inventory (BAI)
Measured: During Pre-inclusion Visit, at consent signature
Questionnaire regarding arousal : Arousal Predisposition Scale (APS)
Measured: During Inclusion Visit, up to 1 month after consent signature
Questionnaire regarding sleep reactivity : Ford Insomnia Response to Stress Test (FIRST)
Measured: During Inclusion Visit, up to 1 month after consent signature
Questionnaire regarding presleep arousal state : Presleep State Arousal Scale (PSAS)
Measured: During Visit V2 (study termination), up to 3 month after consent signature
Questionaire regarding emotional state : Positive and Negative Affect Schedule (PANAS)
Measured: During Visit V2 (study termination), up to 3 month after consent signature
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study start1 Sep 2016
- Primary completion3 Apr 2017
- Study completion3 Apr 2017
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 InsomniaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Institut des Maladies Neurodégénératives (UMR5293)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821234
- Sponsor's protocol ID
- CHUBX 2016/05
- Acronym
- SOMNET
- Status last verified
- Aug 2017
- First submitted
- 17 Jun 2016
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sanz-Arigita E, Daviaux Y, Joliot M, Dilharreguy B, Micoulaud-Franchi JA, Bioulac S, Taillard J, Philip P, Altena E. Brain reactivity to humorous films is affected by insomnia. Sleep. 2021 Sep 13;44(9):zsab081. doi: 10.1093/sleep/zsab081.
PubMed 33772591
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sleepless Brain: Neuroimaging Support for a Differential Diagnosis of Insomnia
- ClinicalTrials.gov ID
- NCT02821234
- Acronym / sponsor ID
- SOMNET / CHUBX 2016/05
- Conditions
- Insomnia
- Keywords
- Insomnia, Hyperarousal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Institut des Maladies Neurodégénératives (UMR5293)
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 3 Apr 2017 (actual)
- Study completion
- 3 Apr 2017 (actual)
- First posted
- 1 Jul 2016 (estimated)
- 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.
One-tenth of the population suffers from insomnia, increasing their risk on other health problems such as depression. Self-reported sleep quality only was historically leading for insomnia diagnosis, but more recently a state of 24-hour hyperarousal has been associated with insomnia, either physiological (increased heart rate, higher frequency EEG) or predominant cognitive-emotional hyperarousal (worry, rumination, repetitive thoughts). Strong evidence shows that those suffering from insomnia with physiological hyperarousal are at higher risk of short and long term severe health problems such as inflammation and hypertension than the group without physiological hyperarousal. The neurophysiological basis of these insomnia phenotypes has however barely been investigated, although its results can have major consequences for how this limiting condition will be treated.
To support the development of a differential diagnosis of insomnia, structural and functional brain connectivity in insomnia patients with different levels of hyperarousal will be investigated and related to sleep variables. Investigators will compare the insomnia group to a normal sleeping control group. Investigators expect that the emotion processing circuit (amygdala-ventromedial prefrontal cortex) is a) more affected in insomniacs compared to normal sleeping controls and b) the directionality of this effect to depend on the level and type of hyperarousal in insomniacs. Further, investigators expect c) amygdala activity to be positive correlated with physiological hyperarousal level and d) prefrontal activity to be positively correlated with cognitive-emotional hyperarousal level. Investigators expect a higher physiological hyperarousal level to be reflected in affected afferent pathways of the amygdala towards the ventromedial prefrontal cortex and investigators expect higher cognitive-emotional hyperarousal to be related to affected efferent pathways from the ventromedial prefrontal cortex to the amygdala. Investigators expect sleep quality to play a mediating role in both types of hyperarousal and their brain activation patterns in insomnia patients and normal sleeping controls.
These data can lead to the definition of new insomnia phenotypes and to new customized and effective insomnia treatment, focused not only on improving sleep but also on changing dysfunctional hyperarousal levels that currently put insomniacs at risk of numerous severe health problems.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insomnia group | Experimental | Other: MRIPatients with insomnia: sleep complaints, of at least 3 nights a week, for at least 3 months, affected daytime functioning, objectified low sleep quality (SE <85%) with 10 days actigraphy occurred in the last 2 months |
| Control group | Experimental | Other: MRIVolunteer without sleep problems either self-reported or objectified through actigraphy (SE ≥85%) |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Insomnia group: patients with insomnia: sleep complaints, of at least 3 nights a week, for at least 3 months, affected daytime functioning.
- control group: no self-reported sleep problems in the last 2 months.
- 20-50 years old.
- Male or female.
- having given written informed consent to participate in the research project.
Key exclusion criteria (14 listed)
- Night and shift-workers.
- Psychiatric disorder: clinical mood disorder, anxiety disorder, psychosis, bipolar disorder.
- For insomnia group: all sleep disorders other than persistent insomnia.
- For control group: all sleep disorders.
- Progressive neurological diseases that include restless legs syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI | Other | Control group, Insomnia group |
Primary outcome
Resting state intrinsic connectivity within the emotion processing network by MRI
Time frame: During Visit V2 (study termination), up to 3 month after consent signature
16 secondary outcomes
Total sleep time obtained by actimetry
Time frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
Sleep efficiency obtained by actimetry
Time frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
Wake after sleep onset obtained by actimetry
Time frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
Sleep latency obtained by actimetry
Time frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
Total sleep time obtained by sleep diary
Time frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
Sleep efficiency obtained by sleep diary
Time frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
Wake after sleep onset obtained by sleep diary
Time frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
sleep latency obtained by sleep diary
Time frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
Questionnaire regarding sleep problems : Pittsburgh Sleep Questionaire (PSQ)
Time frame: During Pre-inclusion Visit, at consent signature
Questionnaire regarding sleep problems : Insomnia Severity Index (ISI)
Time frame: During Pre-inclusion Visit, at consent signature
Questionnaire regarding depression : Beck Depression Inventory (BDI)
Time frame: During Pre-inclusion Visit, at consent signature
Questionnaire regarding anxiety : Beck Anxiety Inventory (BAI)
Time frame: During Pre-inclusion Visit, at consent signature
Questionnaire regarding arousal : Arousal Predisposition Scale (APS)
Time frame: During Inclusion Visit, up to 1 month after consent signature
Questionnaire regarding sleep reactivity : Ford Insomnia Response to Stress Test (FIRST)
Time frame: During Inclusion Visit, up to 1 month after consent signature
Questionnaire regarding presleep arousal state : Presleep State Arousal Scale (PSAS)
Time frame: During Visit V2 (study termination), up to 3 month after consent signature
Questionaire regarding emotional state : Positive and Negative Affect Schedule (PANAS)
Time frame: During Visit V2 (study termination), up to 3 month after consent signature
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
- Derived from this study: PubMed 33772591Sanz-Arigita E, Daviaux Y, Joliot M, Dilharreguy B, Micoulaud-Franchi JA, Bioulac S, Taillard J, Philip P, Altena E. Brain reactivity to humorous films is affected by insomnia. Sleep. 2021 Sep 13;44(9):zsab081. doi: 10.1093/sleep/zsab081.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Insomnia, run by University Hospital, Bordeaux 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 5 inclusion and 14 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: finished, as of the sponsor's last update on 23 Aug 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting state intrinsic connectivity within the emotion processing network by MRI (time frame: During Visit V2 (study termination), up to 3 month after consent signature). 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 NCT02821234, 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 23 Aug 2017.