Functional Imagery of Sleepwalking
1 other identifier
interventional
47
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2016
CompletedFirst Submitted
Initial submission to the registry
July 18, 2016
CompletedFirst Posted
Study publicly available on registry
July 26, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedMay 29, 2024
May 1, 2024
6.2 years
July 18, 2016
May 27, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Brain metabolism measurement with brain scintigraphy
Day 0
Secondary Outcomes (1)
Cortical excitability measurement with transcranial magnetic stimulation
Day 0
Study Arms (3)
Sleepwalker, SW episode
OTHERSleepwalker patients undergo single-photon emission computed tomography during a sleepwalking episode.
Sleepwalkers, slow wave sleep
OTHERSleepwalker patients undergo single-photon emission computed tomography during slow-wave sleep.
Control group
OTHERControl subjects undergo single-photon emission computed tomography during slow-wave sleep.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patient with obstructive sleep apnea Syndrome, restless legs syndrome, nocturnal epilepsy and unstable psychiatric disease.
- CONTROL GROUP
- Affiliated to social security
- Age between 18 years-old and 39 years-old
- Subject with following medical history : NREM parasomnia, neurologic or psychiatric disorder, obstructive sleep apnea syndrome, restless legs syndrome, nocturnal epilepsy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Montpellier
Montpellier, 34295, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2016
First Posted
July 26, 2016
Study Start
April 1, 2010
Primary Completion
June 6, 2016
Study Completion
December 31, 2017
Last Updated
May 29, 2024
Record last verified: 2024-05