Pain Sensitivity in NREM Parasomnia (NOCISOMNIE)

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Status

Sponsorlar

University Hospital, Montpellier

KLINIK SINAQ: NCT02906904

BioSeek: NCT02906904

Açar sözlər

Mücərrəd

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.

Tarixlər

Son Doğrulandı:	05/31/2018
İlk təqdim:	09/05/2016
Təxmini qeydiyyat təqdim edildi:	09/13/2016
İlk Göndərmə:	09/19/2016
Son Yeniləmə Göndərildi:	06/06/2018
Son Yeniləmə Göndərildi:	06/10/2018
Həqiqi Təhsilin Başlama Tarixi:	09/30/2015
Təxmini İlkin Tamamlanma Tarixi:	09/30/2017
Təxmini İşin Tamamlanma Tarixi:	09/30/2017

Vəziyyət və ya xəstəlik

NREM Parasomnia

Sleepwalking

Sleep Terror

Müdaxilə / müalicə

Other: CASE (adult sleepwalking patients)

Other: CONTROL (adult healthy volunteers)

Faza

Qol Qrupları

Qol	Müdaxilə / müalicə
Experimental: CASE (adult sleepwalking patients)	Other: CASE (adult sleepwalking patients) 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
Experimental: CONTROL (adult healthy volunteers)	Other: CONTROL (adult healthy volunteers) 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

Uyğunluq Kriteriyaları

Təhsil üçün uyğun yaşlar	18 Years Üçün 18 Years
Təhsilə Uyğun Cinslər	All
Sağlam Könüllüləri qəbul edir	Bəli
Kriteriyalar	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).

Nəticə

İlkin nəticə tədbirləri

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

İkincili Nəticə Tədbirləri

1. Temperature of the thermoalgic stimulation during wakefulness associated with a nociceptive perception of 5/10 on a visual analogic scale [on inclusion]

2. Minimal temperature of thermoalgic stimulations associated with a neurophysiological arousal response in NREM sleep stage 2 [within 5 seconds]

3. Nociceptive behavioural response [within 5 seconds after a subthreshold thermoalgic stimulations applied during sleep and parasomniac episodes]

Pain Sensitivity in NREM Parasomnia (NOCISOMNIE)

Açar sözlər

chronic pain

baş ağrısı

miqren

sleep deprivation

night terrors

lunatizm

parasomnias