Infra-slow Oscillations During Sleep (SleepD-ISO)
Infra-slow Oscillations During Sleep, After Acute Sleep Deprivation and in Subjects With Restless Legs Syndrome/Periodic Leg Movements During Sleep (RLS/PLMS): an Explorative, Prospective, Monocentric, Observational Case-control and Interventional Study
연구 개요
상세 설명
Sleep is a highly dynamic process and during large parts of sleep the level of arousal fluctuates on a multi-second time scale between the sleep stage specific background and transient, phasic events that clearly arise from this background and constitute the microstructure of sleep. This microstructure is part of the dynamic physiological sleep regulation and at the same time reflects the instability of sleep, is critically involved in the pathophysiology of sleep and a determinant of the recuperative value of sleep and daytime performance.
Intriguingly, these sleep microstructural fluctuations are in a multi-second range that corresponds closely to the so-called infra-slow oscillations that are ubiquitous in the central nervous system. Infra-slow oscillations (0.01 - 0.1 Hz) have been observed in both humans and animals across brain structures and spatial scales in the dynamics of single unit firing rates, direct electrical potential fluctuations and oscillation amplitude modulations. The possibility to record these infra-slow oscillations on the level of the surface EEG with direct current (DC) or Full band (Fb) EEG offers a new approach to study the microstructure of sleep and characterise the full range of sleep-related EEG oscillations.
The objectives of this study are:
- to record and systematically characterise infra-slow oscillations during wake and all stages of sleep
- to explore the relationship between sleep infra-slow oscillations and microstructural events of sleep, in particular the cyclic alternating pattern
- to explore the effect of acute sleep deprivation on sleep infra-slow EEG activity
- to investigate infra-slow sleep EEG activity in patients with RLS/PLMS, common sleep disorders with prominent periodic arousals, heart rate activations, and leg movements
- to explore the relationship between infra-slow EEG oscillations and periodic events in movement and autonomic system activity in patients with RLS/PLMS.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ticino
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Lugano, Ticino, 스위스, 6903
- Neurocenter of Southern Switzerland
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria for all participants:
- Willingness to participate and written informed consent
- Aged 20 to 40 years at the time of screening
- Body mass index (BMI) ≤ 30
Additional inclusion criteria for subjects with RLS/PLMS:
- Either diagnosis of RLS and current IRLS score ≥ 15.
- Or frequent periodic leg movements during sleep
Exclusion criteria for all participants:
- Pregnancy or breast feeding at the time of screening
- Sleep related breathing disorders
- Current psychiatric disorders
- Current chronic treatment that may affect sleep.
- Any significant neurological disorder or other medical disease that may affect sleep.
- Any unstable medical condition.
Additional exclusion criteria for participants with RLS/PLMS:
- Current intake of dopaminergic drugs
- Current intake of other RLS relevant medication
- Intake of hypnotics
- Other significant sleep disorder except symptoms potentially related to RLS
Additional exclusion criteria for healthy participants:
- Any pharmacological treatment that may affect sleep and/or sleep related movement disorders
- Any clinically significant sleep disorders
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Acute sleep deprivation
Registration of habitual sleep and sleep after sleep deprivation
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Participants will stay awake for 36 hours
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Infra-slow frequency power
기간: 36 hours
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Average power (µV) in the infra-slow frequency range during wake and different stages of sleep derived from standard fast fourier transform and continuous wavelet transform.
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36 hours
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Stephany Fulda, PhD, Neurocenter of Southern Switzerland
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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