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Does Hypnosis Improve Severe Sleepwalking ? (HYPNOSOM)

Primary Purpose

Sleepwalking

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hypnosis plus relaxation
Relaxation
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleepwalking focused on measuring Sleepwalking, sleep terrors, arousal disorders, F513 (CIM-10), F514 (CIM-10)

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Groupe Hospitalier Pitié-Salpétrière

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Hypnosis plus relaxation

Relaxation

Arm Description

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)

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Other subjective characteristics of sleepwalking/sleep terrors
total PADSS score
Objective measures of sleepwalking: number of N3 awakenings
Number of N3 awakenings
Objective measures of sleepwalking :behaviors on videoPSG
scale of behaviors on videopSG
% of sleep stages
sleep stages (% of total sleep time)
total sleep time
total sleep time in minute
sleep efficiency
ratio between total sleep time and total sleep period
Spectral EEG (power)
Spectral EEG analysis during hypnotic trance, rest, relaxation and N3 awakenings
Eye movements (number per minute)
EOG during rest, hypnotic trance, relaxation, and N3 awakenings
Muscle tone (amplitude in microvolt)
chin EMG during rest, hypnotic trance, relaxation, and N3 awakenings
Respiration (Rate of breathing per minute)
Respiratory rate and amplitude via impedance belts during rest, hypnotic trance, relaxation, and N3 awakenings
Heart rate (beats per minutes)
heart rate via ECG during rest, hypnotic trance, relaxation, and N3 awakenings
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)
REM sleep without atonia
Per % of tonic and phasic enhanced muscle tone during REM sleep

Full Information

First Posted
December 15, 2015
Last Updated
December 7, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02648568
Brief Title
Does Hypnosis Improve Severe Sleepwalking ?
Acronym
HYPNOSOM
Official Title
Does Hypnosis Improve Severe Sleepwalking ?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleepwalking
Keywords
Sleepwalking, sleep terrors, arousal disorders, F513 (CIM-10), F514 (CIM-10)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypnosis plus relaxation
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Relaxation
Arm Type
Active Comparator
Arm Description
Jacobson relaxation, based on flexion and relaxation of muscles (serves here as a control procedure)
Intervention Type
Behavioral
Intervention Name(s)
Hypnosis plus relaxation
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Relaxation
Other Intervention Name(s)
Jacobson type relaxation
Intervention Description
The patient will have 20 min of Jacobson 's type relaxation, with sequential contraction and relaxation of limb muscles
Primary Outcome Measure Information:
Title
Frequency of sleepwalking episodes as assessed by the PADSS-B
Description
PADSS-B questionnaire, including the frequency of sleepwalking/sleep terrors episodes as evaluated by the patients, from none(0) to (several par nights (6)
Time Frame
at one month (long term)
Secondary Outcome Measure Information:
Title
Other subjective characteristics of sleepwalking/sleep terrors
Description
total PADSS score
Time Frame
At one and at three months
Title
Objective measures of sleepwalking: number of N3 awakenings
Description
Number of N3 awakenings
Time Frame
Night 2 (8 hours) and at one month (long term)
Title
Objective measures of sleepwalking :behaviors on videoPSG
Description
scale of behaviors on videopSG
Time Frame
Night 2 (8 hours) and at one month (long term)
Title
% of sleep stages
Description
sleep stages (% of total sleep time)
Time Frame
Night 2 (8 hours) and at one month (long term)
Title
total sleep time
Description
total sleep time in minute
Time Frame
Night 2 (8 hours) and at one month (long term)
Title
sleep efficiency
Description
ratio between total sleep time and total sleep period
Time Frame
Night 2 (8 hours) and at one month (long term)
Title
Spectral EEG (power)
Description
Spectral EEG analysis during hypnotic trance, rest, relaxation and N3 awakenings
Time Frame
At night 1 (8 hours)
Title
Eye movements (number per minute)
Description
EOG during rest, hypnotic trance, relaxation, and N3 awakenings
Time Frame
At night 1 (8 hours)
Title
Muscle tone (amplitude in microvolt)
Description
chin EMG during rest, hypnotic trance, relaxation, and N3 awakenings
Time Frame
At night 1 (8 hours)
Title
Respiration (Rate of breathing per minute)
Description
Respiratory rate and amplitude via impedance belts during rest, hypnotic trance, relaxation, and N3 awakenings
Time Frame
At night 1 (8 hours)
Title
Heart rate (beats per minutes)
Description
heart rate via ECG during rest, hypnotic trance, relaxation, and N3 awakenings
Time Frame
At night 1 (8 hours)
Title
Frequency of sleepwalking episodes as assessed by the PADSS-B
Description
PADSS-B questionnaire, including the frequency of sleepwalking/sleep terrors episodes as evaluated by the patients, from none(0) to (several par nights (6)
Time Frame
at three months (very long term)
Title
REM sleep without atonia
Description
Per % of tonic and phasic enhanced muscle tone during REM sleep
Time Frame
At night 1 (8 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria >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. Exclusion Criteria < 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ARNULF Isabelle, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Pitié-Salpétrière
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31957639
Citation
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.
Results Reference
derived
PubMed Identifier
28364495
Citation
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.
Results Reference
derived

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Does Hypnosis Improve Severe Sleepwalking ?

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