Clinical trial NCT02648568: Does Hypnosis Improve Severe Sleepwalking ?
Official title: Does Hypnosis Improve Severe Sleepwalking ?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleepwalking
Keywords: Sleepwalking
sleep terrors
arousal disorders
F513 (CIM-10)
F514 (CIM-10)
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 103
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of sleepwalking episodes as assessed by the PADSS-B
timeFrame: at one month (long term)
Secondary outcomes:
measure: Other subjective characteristics of sleepwalking/sleep terrors
timeFrame: At one and at three months
measure: Objective measures of sleepwalking: number of N3 awakenings
timeFrame: Night 2 (8 hours) and at one month (long term)
measure: Objective measures of sleepwalking :behaviors on videoPSG
timeFrame: Night 2 (8 hours) and at one month (long term)
measure: % of sleep stages
timeFrame: Night 2 (8 hours) and at one month (long term)
measure: total sleep time
timeFrame: Night 2 (8 hours) and at one month (long term)
measure: sleep efficiency
timeFrame: Night 2 (8 hours) and at one month (long term)
measure: Spectral EEG (power)
timeFrame: At night 1 (8 hours)
measure: Eye movements (number per minute)
timeFrame: At night 1 (8 hours)
measure: Muscle tone (amplitude in microvolt)
timeFrame: At night 1 (8 hours)
measure: Respiration (Rate of breathing per minute)
timeFrame: At night 1 (8 hours)
measure: Heart rate (beats per minutes)
timeFrame: At night 1 (8 hours)
measure: Frequency of sleepwalking episodes as assessed by the PADSS-B
timeFrame: at three months (very long term)
measure: REM sleep without atonia
timeFrame: At night 1 (8 hours)
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Pitié-Salpétrière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: ARNULF Isabelle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.