Trauma, Nervous SystemSLEEPDOCNCT06766513
Characterization of the Sleep-Wake Cycle in Traumatic Brain Injury Patients with a Disorder of Consciousness
A study testing Actimetry, Subjective assessments and questionnaire in people with Trauma, Nervous System and Brain Trauma, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Each year in France, 160,000 peoples suffer from a mild or severe traumatic brain injury (TBI). Sleep plays a crucial role in the process of brain plasticity, which is essential for neurological and cognitive recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Nervous System, Brain Trauma
- What is being tested?
- Actimetry, Subjective assessments and questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2025to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission to the Post-Resuscitation Rehabilitation Unit or the Neurological Intensive Care Unit
- Consciousness disorders: Vegetative State or Minimally Conscious State (according to the CRS-R)
- Traumatic brain injury
- Patient aged 18 years or older
- Presence of relatives able to express non-opposition to the study
- Subjects affiliated with a social security scheme (or beneficiaries)
Who cannot join
- Admission for status epilepticus
- Individuals admitted to a healthcare or social care facility for purposes other than research
- Adults under legal protection measures (guardianship, conservatorship)
- Individuals not affiliated with a social security scheme or not benefiting from a similar scheme
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anne-Laure CHARLOIS contact
France1 site
Hôpital Neurologique Pierre Wertheimer, Service de Réanimation Polyvalente Neurologique
Bron, France, 69500
Jacques LUAUTE, 04.78.86.51.87 ext. +33, jacques.luaute@chu-lyon.fr
Jacques LUAUTE
About this study
Each year in France, 160,000 peoples suffer from a mild or severe traumatic brain injury (TBI). Sleep plays a crucial role in the process of brain plasticity, which is essential for neurological and cognitive recovery. However, the sleep-wake cycle is rarely, if ever, evaluated in patients with TBI and consciousness disorders within Post-Resuscitation Rehabilitation Units (SRPR). Caregivers develop, on a daily basis, an intuitive understanding of the patient's overall condition. This expertise deserves to be validated using objective sleep assessment tools (actigraphy). If proven accurate, it could lead to the implementation of a sleep-wake cycle evaluation protocol within SRPRs.
- Conditions
- Trauma, Nervous System, Brain Trauma
- Being tested
- Actimetry, Subjective assessments, questionnaire
- Keywords
- Traumatic brain injury, Disorders of consciousness, Vegetative State, Minimally Conscious State
- Medical subject headings
- Trauma, Nervous System, Brain Injuries, Traumatic, Consciousness Disorders, Persistent Vegetative State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActimetryOther
actimetry will be performed continuously during these 104 hours.
Subjective assessmentsOther
The subjective assessments of the patient's awake/sleep state will be collected every 2 hours during the night and at least 3 times during the day, for a total of at least 8 assessments per 24-hour period, over a duration of 104 consecutive hours (slightly more than 4 days, starting at midnight and ending at 8 :00 AM, to cover 4 full days and 4 full nights).
questionnaireOther
MOCA : Montreal Cognitive Assessment
questionnaireOther
SF-36 The Short Form (36)
questionnaireOther
CRS-R (Coma Recovery Scale-Revised)
questionnaireOther
GOSE (Glasgow Outcome Scale-Extended)
questionnaireOther
GCS (Glasgow Coma Scale)
| Study group | Role | What they receive |
|---|---|---|
| Patients in a vegetative state | Experimental | Not described Receives: Other: Actimetry; Other: Subjective assessments; Other: questionnaire |
| Patients in a minimally conscious state | Experimental | Not described Receives: Other: Actimetry; Other: Subjective assessments; Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective assessments
Measured: during 104 consecutive hours after enrollment
Actimetry
Measured: during 104 consecutive hours after enrollment
Secondary outcomes (12)
Coma Recovery Scale-Revised
Measured: once a day for 6 to 5 days
Coma Recovery Scale-Revised
Measured: 3 months after the start of study
Coma Recovery Scale-Revised
Measured: 6 months after the start of study
Glasgow Coma Scale assessment
Measured: once a day for 6 to 5 days
Glasgow Coma Scale assessment
Measured: 3 months after the start of study
Glasgow Coma Scale assessment
Measured: 6 months after the start of study
Glasgow Outcome Scale-Extended assessment
Measured: 6 months after the start of study
Glasgow Outcome Scale-Extended assessment
Measured: 3 months after the start of study
Montreal Cognitive Assessment
Measured: 3 months after the start of study
Montreal Cognitive Assessment
Measured: 6 months after the start of study
Short Form 36 assessment
Measured: 3 months after the start of the study
Short Form 36 assessment
Measured: 6 months after the start of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma, Nervous SystemStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques LUAUTE, Professor, Principal investigator, Hôpital Neurologique Pierre Wertheimer, Service de Service de Rééducation Post-RéanimationFlorent GOBERT, Doctor, Principal investigator, Hôpital Neurologique Pierre Wertheimer, Service de Réanimation Polyvalente Neurologique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766513
- Sponsor's protocol ID
- 69HCL24_0936
- Other IDs
- 2024-A02567-40
- Acronym
- SLEEPDOC
- Status last verified
- Jan 2025
- First submitted
- 16 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Sleep-Wake Cycle in Traumatic Brain Injury Patients with a Disorder of Consciousness
- ClinicalTrials.gov ID
- NCT06766513
- Acronym / sponsor ID
- SLEEPDOC / 69HCL24_0936
- Conditions
- Trauma, Nervous System, Brain Trauma
- Keywords
- Traumatic brain injury, Disorders of consciousness, Vegetative State, Minimally Conscious State
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 9 Jan 2025 (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.
Each year in France, 160,000 peoples suffer from a mild or severe traumatic brain injury (TBI). Sleep plays a crucial role in the process of brain plasticity, which is essential for neurological and cognitive recovery. However, the sleep-wake cycle is rarely, if ever, evaluated in patients with TBI and consciousness disorders within Post-Resuscitation Rehabilitation Units (SRPR). Caregivers develop, on a daily basis, an intuitive understanding of the patient's overall condition. This expertise deserves to be validated using objective sleep assessment tools (actigraphy). If proven accurate, it could lead to the implementation of a sleep-wake cycle evaluation protocol within SRPRs.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients in a vegetative state | Experimental | Other: Actimetry, Other: Subjective assessments, Other: questionnaire |
| Patients in a minimally conscious state | Experimental | Other: Actimetry, Other: Subjective assessments, Other: questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Admission to the Post-Resuscitation Rehabilitation Unit or the Neurological Intensive Care Unit
- Consciousness disorders: Vegetative State or Minimally Conscious State (according to the CRS-R)
- Traumatic brain injury
- Patient aged 18 years or older
- Presence of relatives able to express non-opposition to the study
Key exclusion criteria (4 listed)
- Admission for status epilepticus
- Individuals admitted to a healthcare or social care facility for purposes other than research
- Adults under legal protection measures (guardianship, conservatorship)
- Individuals not affiliated with a social security scheme or not benefiting from a similar scheme
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 |
|---|---|---|
| Actimetryactimetry will be performed continuously during these 104 hours. | Other | Patients in a minimally conscious state, Patients in a vegetative state |
| Subjective assessmentsThe subjective assessments of the patient's awake/sleep state will be collected every 2 hours during the night and at least 3 times during the day, for a total of at least 8 assessments per 24-hour period, over a duration of 104 consecutive hours (slightly more than 4 days, starting at midnight and ending at 8 :00 AM, to cover 4 full days and 4 full nights). | Other | Patients in a minimally conscious state, Patients in a vegetative state |
| questionnaireMOCA : Montreal Cognitive Assessment | Other | Patients in a minimally conscious state, Patients in a vegetative state |
| questionnaireSF-36 The Short Form (36) | Other | Patients in a minimally conscious state, Patients in a vegetative state |
| questionnaireCRS-R (Coma Recovery Scale-Revised) | Other | Patients in a minimally conscious state, Patients in a vegetative state |
| questionnaireGOSE (Glasgow Outcome Scale-Extended) | Other | Patients in a minimally conscious state, Patients in a vegetative state |
| questionnaireGCS (Glasgow Coma Scale) | Other | Patients in a minimally conscious state, Patients in a vegetative state |
Primary outcome
Subjective assessments
Time frame: during 104 consecutive hours after enrollment
Actimetry
Time frame: during 104 consecutive hours after enrollment
12 secondary outcomes
Coma Recovery Scale-Revised
Time frame: once a day for 6 to 5 days
Coma Recovery Scale-Revised
Time frame: 3 months after the start of study
Coma Recovery Scale-Revised
Time frame: 6 months after the start of study
Glasgow Coma Scale assessment
Time frame: once a day for 6 to 5 days
Glasgow Coma Scale assessment
Time frame: 3 months after the start of study
Glasgow Coma Scale assessment
Time frame: 6 months after the start of study
Glasgow Outcome Scale-Extended assessment
Time frame: 6 months after the start of study
Glasgow Outcome Scale-Extended assessment
Time frame: 3 months after the start of study
Montreal Cognitive Assessment
Time frame: 3 months after the start of study
Montreal Cognitive Assessment
Time frame: 6 months after the start of study
Short Form 36 assessment
Time frame: 3 months after the start of the study
Short Form 36 assessment
Time frame: 6 months after the start of study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Anne-Laure CHARLOIS contact
Jacques LUAUTE, Professor principal investigator
Hôpital Neurologique Pierre Wertheimer, Service de Service de Rééducation Post-Réanimation
Florent GOBERT, Doctor principal investigator
Hôpital Neurologique Pierre Wertheimer, Service de Réanimation Polyvalente Neurologique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actimetry, Subjective assessments and questionnaire in people with Trauma, Nervous System and Brain Trauma, run by Hospices Civils de Lyon 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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 9 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacques LUAUTE, professor (04.78.86.51.87 ext. 33, jacques.luaute@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective assessments (time frame: during 104 consecutive hours after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.