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Completed

NCT Number: NCT02648568

Does Hypnosis Improve Severe Sleepwalking ?

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.

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Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe Hospitalier Pitié-Salpétrière

Paris, 75013, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Relaxation

Behavioral

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

Other names: Jacobson type relaxation

Primary outcomes

  1. Frequency of sleepwalking episodes as assessed by the PADSS-B

    Time frame: at one month (long term)

    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 outcomes

  1. Other subjective characteristics of sleepwalking/sleep terrors

    Time frame: At one and at three months

    total PADSS score

  2. Objective measures of sleepwalking: number of N3 awakenings

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

    Number of N3 awakenings

  3. Objective measures of sleepwalking :behaviors on videoPSG

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

    scale of behaviors on videopSG

  4. % of sleep stages

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

    sleep stages (% of total sleep time)

  5. total sleep time

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

    total sleep time in minute

  6. sleep efficiency

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

    ratio between total sleep time and total sleep period

  7. Spectral EEG (power)

    Time frame: At night 1 (8 hours)

    Spectral EEG analysis during hypnotic trance, rest, relaxation and N3 awakenings

  8. Eye movements (number per minute)

    Time frame: At night 1 (8 hours)

    EOG during rest, hypnotic trance, relaxation, and N3 awakenings

  9. Muscle tone (amplitude in microvolt)

    Time frame: At night 1 (8 hours)

    chin EMG during rest, hypnotic trance, relaxation, and N3 awakenings

  10. Respiration (Rate of breathing per minute)

    Time frame: At night 1 (8 hours)

    Respiratory rate and amplitude via impedance belts during rest, hypnotic trance, relaxation, and N3 awakenings

  11. Heart rate (beats per minutes)

    Time frame: At night 1 (8 hours)

    heart rate via ECG during rest, hypnotic trance, relaxation, and N3 awakenings

  12. Frequency of sleepwalking episodes as assessed by the PADSS-B

    Time frame: at three months (very long term)

    PADSS-B questionnaire, including the frequency of sleepwalking/sleep terrors episodes as evaluated by the patients, from none(0) to (several par nights (6)

  13. REM sleep without atonia

    Time frame: At night 1 (8 hours)

    Per % of tonic and phasic enhanced muscle tone during REM sleep

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: HYPNOSOM

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 7, 2016
Registry last updated
Dec 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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