Role of Sleep Reactivity in Shift Work Disorder

Официальное название

Sleep Reactivity as a Novel Mechanism in Shift Work Disorder

Обзор

The purpose of this project is to test sleep reactivity as an independent cause of Shift Work Disorder (SWD). The primary hypothesis is that those with high sleep reactivity will show persistent SWD symptoms after experimental reduction of circadian misalignment, which will then be mitigated with CBT.

Подробное описание

The first aim of this study is to establish sleep reactivity as a predictor of insomnia in SWD independent from circadian misalignment. The second aim of this study is to establish sleep reactivity as a predictor of sleepiness in SWD independent from circadian misalignment. The third aim of this study is to probe sleep reactivity as a cause of insomnia in SWD. The fourth aim of this study is to probe sleep reactivity as a cause of sleepiness in SWD.

Participants with Shift Work Disorder (SWD, N=150) with high and low sleep reactivity will be enrolled. This study will use a two-step mechanistic randomized controlled trial design stratified by high and low sleep reactivity to examine the independent effect of sleep reactivity in SWD after experimental reduction of circadian misalignment. The first step will experimentally reduce circadian misalignment compared to a control. Those who achieve reduced circadian misalignment (melatonin onset at or later than 4am, i.e., compromised phase position) and remain symptomatic will continue to the second step where sleep reactivity will be probed with CBT compared to a sleep education control.

Вмешательства

• Поведенческое Active phototherapy
  Timed bright light exposure delivered in a controlled laboratory setting (10,000 photopic lux) designed to delay the DLMO to 4 am or later.
• Поведенческое Control phototherapy
  Timed less intense light exposure delivered in a controlled laboratory setting (100 photopic lux) that still has a perceptible alerting effect but is not designed to shift circadian phase.
• Поведенческое Cognitive Behavioral Therapy (CBT)
  Cognitive strategies will identify stressors (e.g., dysfunctional beliefs about sleep) and intervene on worry and rumination with cognitive reappraisal and active coping. Sessions will be conducted by a trained behavioral sleep medicine provider via telemedicine to increase accessibility.
• Поведенческое Sleep education control
  Sleep duration recommendations will be equivalent to the CBT group (8 hours of sleep opportunity) to ensure that outcomes are not confounded by time in bed. Materials in the sleep education control condition will be separated into weekly electronic materials monitored for engagement and completion.

Первичные конечные точки

• Dim light melatonin onset [Срок оценки: Within two days of treatment for a duration of 24 hours]
• Sleep reactivity [Срок оценки: Within two weeks of treatment]

Вторичные конечные точки (2)

• Insomnia [Срок оценки: Within one week of post-treatment]
• Sleepiness [Срок оценки: Within one week of post-treamtnet]

Критерии участия

Критерии включения

• Participants must be working a fixed nightshift schedule, operationalized as: a) working at least three night shifts a week, b) shifts must begin between 18:00 and 02:00, and last between 8 to 12 hours, and c) must also plan to maintain the nightshift schedule for the duration of the study
• Participants must have Shift Work Disorder, which will be diagnosed based on ICSD-3 criteria
• Participants must show circadian misalignment, operationalized as a baseline melatonin onset between 18:00 and 01:00.
• Participants must be at least 18 years old

Критерии исключения

• Insomnia disorder or excessive sleepiness predating the onset of shift work
• Termination of nightshift schedule
• Presence of other sleep disorders (e.g. obstructive sleep apnea, narcolepsy) determined by standard clinical polysomnography
• Diagnosis of bipolar disorder
• History of neurological disorders determined by self-report and medical history
• Pregnancy
• Alcohol use disorder
• Illicit drug use via self-report and urine drug screen if reasonable suspicion to test

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• Henry Ford Columbus Medical Center — Novi

Идентификаторы

NCT: NCT05424406 · 15661 · R01HL160870

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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