Pain Sensitivity in NREM Parasomnia (NOCISOMNIE)

NCT ID: NCT02906904

Last Updated: 2018-06-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-10-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

CASE (adult sleepwalking patients)

Group Type: EXPERIMENTAL

Case Intervention

Intervention Type: 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

CONTROL (adult healthy volunteers)

Group Type: EXPERIMENTAL

Control Intervention

Intervention Type: 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

Interventions

Case Intervention

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

Control Intervention

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Montpellier University Hospital

Montpellier, , France

Countries

France

Other Identifiers

9540

Identifier Type: -

Identifier Source: org_study_id