NCT02844231

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 18, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 26, 2016

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

6.2 years

First QC Date

July 18, 2016

Last Update Submit

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

OTHER

Sleepwalker patients undergo single-photon emission computed tomography during a sleepwalking episode.

Other: Single-photon emission computed tomography

Sleepwalkers, slow wave sleep

OTHER

Sleepwalker patients undergo single-photon emission computed tomography during slow-wave sleep.

Other: Single-photon emission computed tomography

Control group

OTHER

Control subjects undergo single-photon emission computed tomography during slow-wave sleep.

Other: Single-photon emission computed tomography

Interventions

Control groupSleepwalker, SW episodeSleepwalkers, slow wave sleep

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

Somnambulism

Condition Hierarchy (Ancestors)

Sleep Arousal DisordersParasomniasSleep Wake DisordersNervous System DiseasesMental Disorders

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

Locations