- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02844231
Functional Imagery of Sleepwalking
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Montpellier, France, 34295
- University Hospital of Montpellier
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
PATIENTS
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Inclusion Criteria:
- Affiliated to social security
- Age between 18 years-old and 39 years-old
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: Sleepwalker, SW episode
Sleepwalker patients undergo single-photon emission computed tomography during a sleepwalking episode.
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Other: Sleepwalkers, slow wave sleep
Sleepwalker patients undergo single-photon emission computed tomography during slow-wave sleep.
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Other: Control group
Control subjects undergo single-photon emission computed tomography during slow-wave sleep.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Brain metabolism measurement with brain scintigraphy
Time Frame: Day 0
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cortical excitability measurement with transcranial magnetic stimulation
Time Frame: Day 0
|
Day 0
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UF 8585
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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