Does Hypnosis Improve Severe Sleepwalking ?

Not Applicable

Completed

• Conditions: Sleepwalking
• Interventions: Behavioral: Relaxation; Behavioral: Hypnosis plus relaxation

• Registration Number: NCT02648568
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The aim of the study is to compare the benefit of two cognitive therapies in severe sleepwalking/ sleep terrors: relaxation vs. relaxation plus hypnosis. This is a monocentric, double-blind controlled study. 75 patients (aged more than 15 yo) with severe sleepwalking (defined as at least one epsidoe per week and at least two awakenings in stage N3 on video polysomngraphy) will be included. All patients will have a visit 1 for diagnosis including a medical interview, a video polysomnography, questionnaires on sleepwalking (PADSS and systematized interview), sleep quality (PSQI, MEQ) and sleepiness (Epworth scale) and suggestibility scale. 25 patients will be randomized to the relaxation group, 25 patients to the hypnosis plus relaxation group, while the 25 non-randomized patients will be non-treated controls. Randomized patients will receive the therapy on day 1, and be monitored during the subsequent night. They will have a weekly therapy for 4 additional sessions and be monitored again on Month 1, as well as they will complete the sleep and sleepwalking questionnaires. They will also complete the questionnaire by phone on Month 3. The non-randomized controls will complete the questionnaire on month 1, with no therapeutical intervention between Day 1 and Month 1. The main outcome will be the frequency of sleepwalking episodes, as assessed by the PADSS-B. Secondary outcomes include the changes in other subitems of teh PADSS, of the N3 awakenings in v-PSG between night 1 and Night 2 (short term effect) and Night 1 and Night 28 (long term effect), as well as changes in sleep quality and sleepiness scales. A comparison of spectral EEG, as well as respiration, eye movements, muscle tone and heart rate during rest, hypnosis trance, relaxation and sleepwalking episodes is also scheduled.

Detailed Description

Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-12-15
• Study First Submitted QC: 2016-01-05
• Study First Posted: 2016-01-07
• Status Verified: 2017-09
• Primary Completion: 2017-11
• Study Completion: 2017-12
• Last Update Submitted: 2017-12-07
• Last Update Posted: 2017-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Relaxation	Relaxation	Jacobson relaxation, based on flexion and relaxation of muscles (serves here as a control procedure)
Hypnosis plus relaxation	Hypnosis plus relaxation	Ericksonian hypnosis, based on sensations when awakening partially during N3 ; Jacobson relaxation, based on flexion and relaxation of muscles (serves here as a control procedure)

Primary Outcome Measures

Name	Time	Method
Frequency of sleepwalking episodes as assessed by the PADSS-B	at one month (long term)	PADSS-B questionnaire, including the frequency of sleepwalking/sleep terrors episodes as evaluated by the patients, from none(0) to (several par nights (6)

Secondary Outcome Measures

Name	Time	Method
Respiration (Rate of breathing per minute)	At night 1 (8 hours)	Respiratory rate and amplitude via impedance belts during rest, hypnotic trance, relaxation, and N3 awakenings
Heart rate (beats per minutes)	At night 1 (8 hours)	heart rate via ECG during rest, hypnotic trance, relaxation, and N3 awakenings
Frequency of sleepwalking episodes as assessed by the PADSS-B	at three months (very long term)	PADSS-B questionnaire, including the frequency of sleepwalking/sleep terrors episodes as evaluated by the patients, from none(0) to (several par nights (6)
REM sleep without atonia	At night 1 (8 hours)	Per % of tonic and phasic enhanced muscle tone during REM sleep
Other subjective characteristics of sleepwalking/sleep terrors	At one and at three months	total PADSS score
Objective measures of sleepwalking: number of N3 awakenings	Night 2 (8 hours) and at one month (long term)	Number of N3 awakenings
Objective measures of sleepwalking :behaviors on videoPSG	Night 2 (8 hours) and at one month (long term)	scale of behaviors on videopSG
% of sleep stages	Night 2 (8 hours) and at one month (long term)	sleep stages (% of total sleep time)
total sleep time	Night 2 (8 hours) and at one month (long term)	total sleep time in minute
sleep efficiency	Night 2 (8 hours) and at one month (long term)	ratio between total sleep time and total sleep period
Spectral EEG (power)	At night 1 (8 hours)	Spectral EEG analysis during hypnotic trance, rest, relaxation and N3 awakenings
Eye movements (number per minute)	At night 1 (8 hours)	EOG during rest, hypnotic trance, relaxation, and N3 awakenings
Muscle tone (amplitude in microvolt)	At night 1 (8 hours)	chin EMG during rest, hypnotic trance, relaxation, and N3 awakenings

Trial Locations

Locations (1)

Groupe Hospitalier Pitié-Salpétrière; 🇫🇷 Paris, France