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Pain Sensitivity in NREM Parasomnia (NOCISOMNIE) (NOCISOMNIE)

Primary Purpose

NREM Parasomnia, Sleepwalking, Sleep Terror

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Case Intervention
Control Intervention
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for NREM Parasomnia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subject from 18 years-old to 45 years-old
  • Affiliated to social security
  • Written informed consent

    * CASE specific inclusion criteria :

  • NREM parasomnia diagnosed according to the International Classification of Sleep Disorders 3rd edition (ICSD-3) criteria and confirmed by polysomnography assessment
  • Frequent symptomatology (at least 1 episode by week in the past 3 months)

    * CONTROL specific inclusion criteria :

  • No medical history of NREM parasomnia

Exclusion Criteria:

  • Known skin allergy to metal
  • Use of psychotropic drugs during the 15 days before the inclusion
  • Use of analgesic drugs during the 15 days before the inclusion
  • A diagnosis of sleep apnea syndrome, periodic limb movements or restless legs syndrome present more than twice a week
  • Medical history of epilepsy
  • Non stable psychiatric disorder
  • Pregnancy, breastfeeding
  • Subject deprived of liberty or protected by law (tutorship, curatorship).

Sites / Locations

  • Montpellier University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CASE (adult sleepwalking patients)

CONTROL (adult healthy volunteers)

Arm Description

Outcomes

Primary Outcome Measures

Percentage of neurophysiological arousal response within 5 seconds after a subthreshold thermoalgic stimulation applied during parasomniac episodes.

Secondary Outcome Measures

Temperature of the thermoalgic stimulation during wakefulness associated with a nociceptive perception of 5/10 on a visual analogic scale
Minimal temperature of thermoalgic stimulations associated with a neurophysiological arousal response in NREM sleep stage 2
Nociceptive behavioural response

Full Information

First Posted
September 6, 2016
Last Updated
June 7, 2018
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02906904
Brief Title
Pain Sensitivity in NREM Parasomnia (NOCISOMNIE)
Acronym
NOCISOMNIE
Official Title
Objective Measures of Pain Sensitivity in NREM Sleep Parasomnia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Material needed for study was not available
Study Start Date
October 2015 (Anticipated)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

5. Study Description

Brief Summary
Non Rapid Eye Movement (NREM) sleep parasomnias (sleepwalking and sleep terrors) are frequent and disabling sleep disorders characterized by arousal specifically from slow wave sleep (SWS) with dissociated brain activity that may be related to lower nociceptive state. The investigators recently reported frequent subjective complaints of chronic pain, migraine and headache during wakefulness in adult sleepwalkers. They also described frequent analgesia during severe and injuring episodes, suggesting a relationship between dissociated brain activity and nociceptive dysregulation. However, this study did not included objective nociceptive measures and the retrospective assessment of perceived pain during parasomnia episodes over a lifetime span might also introduce a recall bias. The aims of the present study are to measure objective pain sensitivity in patients with NREM parasomnias and matched controls during 1) parasomniac episodes, 2) light NREM sleep and SWS, and 3) wakefulness. Fifteen adults with severe NREM parasomnia and 15 age and sex-matched controls will be recruited. A 25 hours (8 AM to 9 AM) sleep deprivation protocol followed by auditory stimulations during SWS will be used to trigger parasomniac episodes. Thermoalgic stimulations of graduate intensity will be applied during wakefulness (8 PM) to determine the nociceptive threshold. During the recovery sleep following the sleep deprivation, the investigators will apply repeated subthreshold thermoalgic stimulations in NREM stage 2, SWS and triggered parasomniac episodes and report the behavioural/neurophysiologic nociceptive responses. The investigators hypothesized a lower nociceptive threshold during wakefulness in sleepwalkers and a decrease of the arousabiliy during SWS and parasomniac episodes. This study may help to better understand the etiology and mechanisms underlying the clinical enigma of the nociceptive dysregulation in NREM sleep parasomnias.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NREM Parasomnia, Sleepwalking, Sleep Terror

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CASE (adult sleepwalking patients)
Arm Type
Experimental
Arm Title
CONTROL (adult healthy volunteers)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Case Intervention
Intervention Description
24-hour sleep deprivation protocol, polysomnographic monitoring of the recovery sleep, triggering of parasomniac episodes by auditory stimulations, thermoalgic stimulation (Modulator Sensory Analyzer Thermal Stimulator®) during wakefulness, parasomniac episodes, NREM stage 2 ans SWS
Intervention Type
Other
Intervention Name(s)
Control Intervention
Intervention Description
24-hour sleep deprivation protocol, polysomnographic monitoring of the recovery sleep, thermoalgic stimulation (Modulator Sensory Analyzer Thermal Stimulator®) during wakefulness, NREM stage 2 ans SWS
Primary Outcome Measure Information:
Title
Percentage of neurophysiological arousal response within 5 seconds after a subthreshold thermoalgic stimulation applied during parasomniac episodes.
Time Frame
within 5 seconds after stimulation
Secondary Outcome Measure Information:
Title
Temperature of the thermoalgic stimulation during wakefulness associated with a nociceptive perception of 5/10 on a visual analogic scale
Time Frame
on inclusion
Title
Minimal temperature of thermoalgic stimulations associated with a neurophysiological arousal response in NREM sleep stage 2
Time Frame
within 5 seconds
Title
Nociceptive behavioural response
Time Frame
within 5 seconds after a subthreshold thermoalgic stimulations applied during sleep and parasomniac episodes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject from 18 years-old to 45 years-old Affiliated to social security Written informed consent * CASE specific inclusion criteria : NREM parasomnia diagnosed according to the International Classification of Sleep Disorders 3rd edition (ICSD-3) criteria and confirmed by polysomnography assessment Frequent symptomatology (at least 1 episode by week in the past 3 months) * CONTROL specific inclusion criteria : No medical history of NREM parasomnia Exclusion Criteria: Known skin allergy to metal Use of psychotropic drugs during the 15 days before the inclusion Use of analgesic drugs during the 15 days before the inclusion A diagnosis of sleep apnea syndrome, periodic limb movements or restless legs syndrome present more than twice a week Medical history of epilepsy Non stable psychiatric disorder Pregnancy, breastfeeding Subject deprived of liberty or protected by law (tutorship, curatorship).
Facility Information:
Facility Name
Montpellier University Hospital
City
Montpellier
Country
France

12. IPD Sharing Statement

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Pain Sensitivity in NREM Parasomnia (NOCISOMNIE)

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