Functional Imagery of Sleepwalking
Primary Purpose
Sleepwalking
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Single-photon emission computed tomography
Sponsored by
About this trial
This is an interventional basic science trial for Sleepwalking
Eligibility Criteria
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.
Sites / Locations
- University Hospital of Montpellier
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Sleepwalker, SW episode
Sleepwalkers, slow wave sleep
Control group
Arm Description
Sleepwalker patients undergo single-photon emission computed tomography during a sleepwalking episode.
Sleepwalker patients undergo single-photon emission computed tomography during slow-wave sleep.
Control subjects undergo single-photon emission computed tomography during slow-wave sleep.
Outcomes
Primary Outcome Measures
Brain metabolism measurement with brain scintigraphy
Secondary Outcome Measures
Cortical excitability measurement with transcranial magnetic stimulation
Full Information
NCT ID
NCT02844231
First Posted
July 18, 2016
Last Updated
July 21, 2016
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT02844231
Brief Title
Functional Imagery of Sleepwalking
Official Title
Functional Imagery of Sleepwalking
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleepwalking
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sleepwalker, SW episode
Arm Type
Other
Arm Description
Sleepwalker patients undergo single-photon emission computed tomography during a sleepwalking episode.
Arm Title
Sleepwalkers, slow wave sleep
Arm Type
Other
Arm Description
Sleepwalker patients undergo single-photon emission computed tomography during slow-wave sleep.
Arm Title
Control group
Arm Type
Other
Arm Description
Control subjects undergo single-photon emission computed tomography during slow-wave sleep.
Intervention Type
Other
Intervention Name(s)
Single-photon emission computed tomography
Primary Outcome Measure Information:
Title
Brain metabolism measurement with brain scintigraphy
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Cortical excitability measurement with transcranial magnetic stimulation
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University Hospital of Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
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Functional Imagery of Sleepwalking
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