Pain Sensitivity in NREM Parasomnia (NOCISOMNIE)

NCT02906904 | Withdrawn

• 1 other identifier: 9540
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

NREM Parasomnia; Sleepwalking; Sleep Terror

Outcome Measures

Primary Outcomes (1)

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

  within 5 seconds after stimulation

Secondary Outcomes (3)

• Temperature of the thermoalgic stimulation during wakefulness associated with a nociceptive perception of 5/10 on a visual analogic scale

  on inclusion

• Minimal temperature of thermoalgic stimulations associated with a neurophysiological arousal response in NREM sleep stage 2

  within 5 seconds

• Nociceptive behavioural response

  within 5 seconds after a subthreshold thermoalgic stimulations applied during sleep and parasomniac episodes

Study Arms (2)

CASE (adult sleepwalking patients)

EXPERIMENTAL

Other: Case Intervention

CONTROL (adult healthy volunteers)

EXPERIMENTAL

Other: Control Intervention

Interventions

Case Intervention OTHER

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

CASE (adult sleepwalking patients)

Control Intervention OTHER

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

CONTROL (adult healthy volunteers)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject from 18 years-old to 45 years-old
• Affiliated to social security
• Written informed consent
• 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)
• No medical history of NREM parasomnia

You may not qualify if:

• Known skin allergy to metal
• 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).

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Montpellier University Hospital

Montpellier, France

Location

MeSH Terms

Conditions

Somnambulism; Night Terrors

Condition Hierarchy (Ancestors)

Sleep Arousal Disorders; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 20, 2016
• Study Start: October 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: June 11, 2018

Record last verified: 2018-06

Locations

FR (1)