ACTRN12622000940774招募中未知
A Scalable Insomnia Program during the Pregnancy and Postpartum Periods: An Effectiveness-Implementation Hybrid Trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 384
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •(a) Expectant mothers and birthing parents who are aged 18 years or older;
- •(b) At least 26 weeks but no more than 32 weeks gestation;
- •(c) Able to communicate in English;
- •(d) Have regular access to email and the internet.
- •(e) Currently live in Australia
- •(f) Score above 7 on the Insomnia Severity Index (ISI; Bastien, Vallières, & Morin, 2001)
排除标准
- •(a) Participants who use medications or substance that directly affect sleep (including sleep medications, melatonin, cannabis, etc.); stable use of psychotrophic medications for the treatment of non-sleep related conditions (e.g., antidepressant, anxiolytics) are not exclusionary but will be assessed on case to case basis and any changes in doses will be documented.
- •(b) Unstable medical conditions that directly and significantly affect sleep; determined case to case.
- •(c) Participants who self-report a current diagnosis of the following sleep disorders, AND symptoms significantly affecting sleep duration and quality:
- •- Sleep apnea: loud snoring OR observed gasping or pauses in breathing OR previously diagnosed with apnea hypopnea index >15 but not/inadequately treated
- •- Periodic Limb Movement Disorder with arousal index > 15
- •- Restless Legs Syndrome (RLS) occurring 3 times/week, with duration of at least one month and onset prior to pregnancy. Not exclusionary if RLS increased or emerged during pregnancy (as long as pre-pregnancy frequency was no more than once a week before pregnancy).
- •- Severe circadian rhythm disorders:
- •o Irregular Sleep Wake Disorder
- •o Non-24-Hour Sleep-Wake Syndrome
- •o Advance Sleep-Phase Syndrome (if habitual bed time is earlier than 8 pm and habitual wake time is earlier than 4 am. Occasional deviation from this schedule is allowed.)
- •o Delayed Sleep-Phase Syndrome (if habitual bed time is later than 3 am and habitual wake time is later than 11 am. Occasional deviation from this schedule is allowed.)
- •(d) Fixed night shift work between midnight and 5 a.m., or rotating work schedules that require night shifts during the course of their pregnancy or during their participation
- •(e) Narcolepsy
- •(f) Other previously diagnosed sleep disorders – if severe (discuss with PI)
研究者
相似试验
已完成
不适用
Telemedicine Mindfulness-based Therapy for Perinatal Insomnia: An Open-label Trial.InsomniaNCT04443959Henry Ford Health System12
尚未招募
Unknown
Development of a program to improve sleepiness in university studentsHealthy adultsJPRN-UMIN000053158Fukushima Medical University20
招募中
不适用
The Dream Team: Testing Implementation of a Sleep Intervention for Perinatal Women Delivered by Direct Care WorkersSleepPregnancy RelatedInsomniaSleep DeprivationSleep HygieneSleep DisturbancePostpartum DepressionNCT06737055Rhode Island Hospital55
招募中
不适用
Brief Cognitive Behavioural Therapy for Insomnia Versus Sleep Hygiene for Sleep Difficulties in Early PregnancySleep DisturbancePerinatal AnxietyPerinatal DepressionNCT05710991St. Joseph's Healthcare Hamilton102
已完成
不适用
Evaluation of an Innovative Sleep Intervention for the Prevention of Sudden Unexpected Death in Infancy in a cohort of Maori and Pacific Infants in South Auckland New Zealand.Sudden unexpected death in children (SUDI)Public Health - Health service researchACTRN12616001427460Middlemore Hospital240