Does Hypnosis Improve Severe Sleepwalking ?

Sleepwalking Clinical Trial

— HYPNOSOM  

Official title:

Does Hypnosis Improve Severe Sleepwalking ?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02648568
• Other study ID #: P130603
• Secondary ID: 2014-A00791-46
• Status: Completed
• Phase: N/A
• First received: December 15, 2015
• Last updated: December 7, 2017
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: September 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sleepwalking

Intervention

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

Locations

Country	Name	City	State
France	Groupe Hospitalier Pitié-Salpétrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Other subjective characteristics of sleepwalking/sleep terrors	total PADSS score	At one and at three months
Secondary	Objective measures of sleepwalking: number of N3 awakenings	Number of N3 awakenings	Night 2 (8 hours) and at one month (long term)
Secondary	Objective measures of sleepwalking :behaviors on videoPSG	scale of behaviors on videopSG	Night 2 (8 hours) and at one month (long term)
Secondary	% of sleep stages	sleep stages (% of total sleep time)	Night 2 (8 hours) and at one month (long term)
Secondary	total sleep time	total sleep time in minute	Night 2 (8 hours) and at one month (long term)
Secondary	sleep efficiency	ratio between total sleep time and total sleep period	Night 2 (8 hours) and at one month (long term)
Secondary	Spectral EEG (power)	Spectral EEG analysis during hypnotic trance, rest, relaxation and N3 awakenings	At night 1 (8 hours)
Secondary	Eye movements (number per minute)	EOG during rest, hypnotic trance, relaxation, and N3 awakenings	At night 1 (8 hours)
Secondary	Muscle tone (amplitude in microvolt)	chin EMG during rest, hypnotic trance, relaxation, and N3 awakenings	At night 1 (8 hours)
Secondary	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)
Secondary	Heart rate (beats per minutes)	heart rate via ECG during rest, hypnotic trance, relaxation, and N3 awakenings	At night 1 (8 hours)
Secondary	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)
Secondary	REM sleep without atonia	Per % of tonic and phasic enhanced muscle tone during REM sleep	At night 1 (8 hours)