Does Hypnosis Improve Severe Sleepwalking ? (HYPNOSOM)

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.

Study Overview

• Status: Completed
• Conditions: Sleepwalking
• Intervention / Treatment: Behavioral: Hypnosis plus relaxation; Behavioral: Relaxation

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 Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Groupe Hospitalier Pitie-Salpetriere

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

1. >15 years old
2. French speaker
3. having signed the Informed consent form
4. Affiliated to National Health Insurance
5. Sleepwalking or sleep terrors (ICSD-3 criteria);
6. At least 2 awakenings from N3 on Night 1 videopolysomnography;
7. At least one episode per week.

Exclusion Criteria

1. < 15 years old
2. Patient under guardian ship
3. Patient unable to understand the protocol
4. Patient unable, from investigator's opinion, to comply to the procedures of the trial, including the ability to practice self-hypnosis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	Behavioral: Hypnosis plus relaxation; The patient will have 20 min of Jacobson 's type relaxation, with sequential contraction and relaxation of limb muscles followed by an induction of hypnosis based on the preferential channel of each patient and, during trance, recommendation to assimilter the bed room and bed to a safe place
Active Comparator: Relaxation; Jacobson relaxation, based on flexion and relaxation of muscles (serves here as a control procedure)	Behavioral: Relaxation; The patient will have 20 min of Jacobson 's type relaxation, with sequential contraction and relaxation of limb muscles; Other Names: Jacobson type relaxation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: ARNULF Isabelle, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• Barros A, Uguccioni G, Salkin-Goux V, Leu-Semenescu S, Dodet P, Arnulf I. Simple behavioral criteria for the diagnosis of disorders of arousal. J Clin Sleep Med. 2020 Jan 15;16(1):121-128. doi: 10.5664/jcsm.8136. Epub 2019 Dec 4.
• Dubessy AL, Leu-Semenescu S, Attali V, Maranci JB, Arnulf I. Sexsomnia: A Specialized Non-REM Parasomnia? Sleep. 2017 Feb 1;40(2). doi: 10.1093/sleep/zsw043.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: December 15, 2015
• First Submitted That Met QC Criteria: January 5, 2016
• First Posted (Estimate): January 7, 2016

Study Record Updates

• Last Update Posted (Actual): December 8, 2017
• Last Update Submitted That Met QC Criteria: December 7, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Sleepwalking; sleep terrors; arousal disorders; F513 (CIM-10); F514 (CIM-10)
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Parasomnias; Sleep Arousal Disorders; Somnambulism
• Other Study ID Numbers: P130603; 2014-A00791-46 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No