Does Hypnosis Improve Severe Sleepwalking ?

NCT02648568 | Completed

• 2 other identifiers: P1306032014-A00791-46
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleepwalking

Keywords

Sleepwalking; sleep terrors; arousal disorders; F513 (CIM-10); F514 (CIM-10)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Other subjective characteristics of sleepwalking/sleep terrors

  At one and at three months

• Objective measures of sleepwalking: number of N3 awakenings

  Night 2 (8 hours) and at one month (long term)

• Objective measures of sleepwalking :behaviors on videoPSG

  Night 2 (8 hours) and at one month (long term)

• % of sleep stages

  Night 2 (8 hours) and at one month (long term)

• total sleep time

  Night 2 (8 hours) and at one month (long term)

Study Arms (2)

Hypnosis plus relaxation

ACTIVE COMPARATOR

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

Relaxation

ACTIVE COMPARATOR

Jacobson relaxation, based on flexion and relaxation of muscles (serves here as a control procedure)

Behavioral: Relaxation

Interventions

Hypnosis plus relaxation BEHAVIORAL

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

Hypnosis plus relaxation

Relaxation BEHAVIORAL

The patient will have 20 min of Jacobson 's type relaxation, with sequential contraction and relaxation of limb muscles

Also known as: Jacobson type relaxation

Relaxation

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Groupe Hospitalier Pitié-Salpétrière

Paris, 75013, France

Location

Related Publications (2)

• 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.

  PMID: 31957639 DERIVED

• 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.

  PMID: 28364495 DERIVED

MeSH Terms

Conditions

Somnambulism; Night Terrors

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Sleep Arousal Disorders; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• ARNULF Isabelle, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: January 7, 2016
• Study Start: January 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 8, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)