SleepwalkingNCT02844231
Functional Imagery of Sleepwalking
A study testing Single-photon emission computed tomography in people with Sleepwalking, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Sleepwalking (also called somnambulism) is a disorder in which only SWS is disrupted. This NREM parasomnia is characterized by inappropriate motor behaviors, usually initiated during arousal from SWS, that induce psychological distress and alter quality of life, leading to fatigue, excessive daytime sleepiness, and… Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleepwalking
- What is being tested?
- Single-photon emission computed tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2010to 31 Dec 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 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject diagnosed with NREM parasomnia according the international classification of sleep disorders
- More than one episode per week
- More than one hypersynchronous delta wave arousal recorded on polysomnographic assessment
- Affiliated to social security
- Age between 18 years-old and 39 years-old
- Affiliated to social security
- Age between 18 years-old and 39 years-old
Who cannot join
- Patient taking any psychotropic drug during the two weeks before the inclusion
- Patient with obstructive sleep apnea Syndrome, restless legs syndrome, nocturnal epilepsy and unstable psychiatric disease.
- CONTROL GROUP
- Subject taking psychotropic drug during the two weeks before the inclusion
- Subject with following medical history : NREM parasomnia, neurologic or psychiatric disorder, obstructive sleep apnea syndrome, restless legs syndrome, nocturnal epilepsy.
Trial locations and contacts
1 site in 1 country.
About this study
Sleepwalking (also called somnambulism) is a disorder in which only SWS is disrupted. This NREM parasomnia is characterized by inappropriate motor behaviors, usually initiated during arousal from SWS, that induce psychological distress and alter quality of life, leading to fatigue, excessive daytime sleepiness, and objectively impaired vigilance in the morning.
The pathophysiology of sleepwalking remains poorly understood. Sleepwalkers had difficulty maintaining stable, consolidated sleep and experienced more arousals and microarousals, specifically from SWS, leading to increased NREM instability, especially during the first sleep cycles. The brain is partially awake, resulting in behavioral manifestations, and partially in NREM sleep, resulting in no conscious awareness of actions.
Read more
A Single Photonic Emission Computed Tomography (SPECT) study of one sleepwalking episode found increased activation in the posterior cingulate cortex and cerebellum, with deactivation in the frontoparietal associative cortices. Data from intracerebral EEGs during confusional arousals confirmed both local arousal of the motor and cingulate cortices and increased delta activity in the frontoparietal associative cortices.
The investigators thus proposed a controlled study of SPECT imagery in 24 sleepwalkers (12 SPECT during a SW episode and 12 SPECT during slow wave sleep and 24 during wakefulness) and 12 controls (during slow wave sleep and wakefulness). SW episodes will be elicited by sleep deprivation condition associated with forced arousal (auditory stimulus).
The comparative analyses of SPECT acquisitions between different states (wakefulness, slow wave sleep and SW) and populations (sleepwalkers versus controls) will provide new insights about the complex pathophysiology of SW episodes.
- Conditions
- Sleepwalking
- Being tested
- Single-photon emission computed tomography
- Medical subject headings
- Somnambulism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-photon emission computed tomographyOther
| Study group | Role | What they receive |
|---|---|---|
| Sleepwalker, SW episode | Other | Sleepwalker patients undergo single-photon emission computed tomography during a sleepwalking episode. Receives: Other: Single-photon emission computed tomography |
| Sleepwalkers, slow wave sleep | Other | Sleepwalker patients undergo single-photon emission computed tomography during slow-wave sleep. Receives: Other: Single-photon emission computed tomography |
| Control group | Other | Control subjects undergo single-photon emission computed tomography during slow-wave sleep. Receives: Other: Single-photon emission computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain metabolism measurement with brain scintigraphy
Measured: Day 0
Secondary outcomes (1)
Cortical excitability measurement with transcranial magnetic stimulation
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startApr 2010
- Primary completion6 Jun 2016
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepwalkingStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844231
- Sponsor's protocol ID
- UF 8585
- Status last verified
- May 2024
- First submitted
- 18 Jul 2016
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Imagery of Sleepwalking
- ClinicalTrials.gov ID
- NCT02844231
- Acronym / sponsor ID
- UF 8585
- Conditions
- Sleepwalking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Apr 2010 (actual)
- Primary completion
- 6 Jun 2016 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 26 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.
Sleepwalking (also called somnambulism) is a disorder in which only SWS is disrupted. This NREM parasomnia is characterized by inappropriate motor behaviors, usually initiated during arousal from SWS, that induce psychological distress and alter quality of life, leading to fatigue, excessive daytime sleepiness, and objectively impaired vigilance in the morning.
The pathophysiology of sleepwalking remains poorly understood. Sleepwalkers had difficulty maintaining stable, consolidated sleep and experienced more arousals and microarousals, specifically from SWS, leading to increased NREM instability, especially during the first sleep cycles. The brain is partially awake, resulting in behavioral manifestations, and partially in NREM sleep, resulting in no conscious awareness of actions.
A Single Photonic Emission Computed Tomography (SPECT) study of one sleepwalking episode found increased activation in the posterior cingulate cortex and cerebellum, with deactivation in the frontoparietal associative cortices. Data from intracerebral EEGs during confusional arousals confirmed both local arousal of the motor and cingulate cortices and increased delta activity in the frontoparietal associative cortices.
The investigators thus proposed a controlled study of SPECT imagery in 24 sleepwalkers (12 SPECT during a SW episode and 12 SPECT during slow wave sleep and 24 during wakefulness) and 12 controls (during slow wave sleep and wakefulness). SW episodes will be elicited by sleep deprivation condition associated with forced arousal (auditory stimulus).
The comparative analyses of SPECT acquisitions between different states (wakefulness, slow wave sleep and SW) and populations (sleepwalkers versus controls) will provide new insights about the complex pathophysiology of SW episodes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sleepwalker, SW episode | Other | Other: Single-photon emission computed tomographySleepwalker patients undergo single-photon emission computed tomography during a sleepwalking episode. |
| Sleepwalkers, slow wave sleep | Other | Other: Single-photon emission computed tomographySleepwalker patients undergo single-photon emission computed tomography during slow-wave sleep. |
| Control group | Other | Other: Single-photon emission computed tomographyControl subjects undergo single-photon emission computed tomography during slow-wave sleep. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject diagnosed with NREM parasomnia according the international classification of sleep disorders
- More than one episode per week
- More than one hypersynchronous delta wave arousal recorded on polysomnographic assessment
- Affiliated to social security
- Age between 18 years-old and 39 years-old
Key exclusion criteria (5 listed)
- Patient taking any psychotropic drug during the two weeks before the inclusion
- Patient with obstructive sleep apnea Syndrome, restless legs syndrome, nocturnal epilepsy and unstable psychiatric disease.
- CONTROL GROUP
- Subject taking psychotropic drug during the two weeks before the inclusion
- Subject with following medical history : NREM parasomnia, neurologic or psychiatric disorder, obstructive sleep apnea syndrome, restless legs syndrome, nocturnal epilepsy.
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 |
|---|---|---|
| Single-photon emission computed tomography | Other | Control group, Sleepwalker, SW episode, Sleepwalkers, slow wave sleep |
Primary outcome
Brain metabolism measurement with brain scintigraphy
Time frame: Day 0
1 secondary outcome
Cortical excitability measurement with transcranial magnetic stimulation
Time frame: Day 0
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 29 May 2024.
Related trials for Sleepwalking
Not yet recruiting
Acoustic Stimulation to Study and Modulate Sleepwalking and Related Arousal Disorders
NREM Parasomnias, Sleepwalking
Recruiting
Development and Online Evaluation of an Online Course for Parasomnias
Sleep Terror, Sleepwalking
RecruitingObservational study
Mainz Register of Patients With Sleep Disorders
Sleep Disorder, Sleep Disorder Parasomnia
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 Single-photon emission computed tomography in people with Sleepwalking, run by University Hospital, Montpellier 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 7 inclusion and 5 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 29 May 2024. 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?
Brain metabolism measurement with brain scintigraphy (time frame: Day 0). 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 29 May 2024.