Overview

This trial is active, not recruiting.

Condition sleepwalking
Treatment single-photon emission computed tomography
Sponsor University Hospital, Montpellier
Start date April 2010
End date December 2016
Trial size 36 participants
Trial identifier NCT02844231, UF 8585

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model parallel assignment
Masking single blind (subject)
Primary purpose basic science
Arm
(Other)
Sleepwalker patients undergo single-photon emission computed tomography during a sleepwalking episode.
single-photon emission computed tomography
(Other)
Sleepwalker patients undergo single-photon emission computed tomography during slow-wave sleep.
single-photon emission computed tomography
(Other)
Control subjects undergo single-photon emission computed tomography during slow-wave sleep.
single-photon emission computed tomography

Primary Outcomes

Measure
Brain metabolism measurement with brain scintigraphy
time frame: Day 0

Secondary Outcomes

Measure
Cortical excitability measurement with transcranial magnetic stimulation
time frame: Day 0

Eligibility Criteria

Male or female participants from 18 years up to 39 years old.

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.

Additional Information

Official title Functional Imagery of Sleepwalking
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University Hospital, Montpellier.