Clinical Trial: Does Hypnosis Improve Severe Sleepwalking ?

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Does Hypnosis Improve Severe Sleepwalking ?

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 Summary: 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
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: 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)


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: December 15, 2015
Date Started: January 2015
Date Completion: January 2018
Last Updated: October 7, 2016
Last Verified: September 2016