SHINE: Sleep Health In Perinatal Care

Not Applicable

Recruiting

• Conditions: Insomnia; Sleep Disturbance; Mental Health - Other mental health disorders; Reproductive Health and Childbirth - Childbirth and postnatal care; Neurological - Other neurological disorders; Public Health - Health service research

• Registration Number: ACTRN12622000940774
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 384

Inclusion Criteria

(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)

Exclusion Criteria

(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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is insomnia symptom severity measured via the Insomnia Severity Index total score (ISI; Bastien, Vallieres & Morin, 2001)[ There are two primary endpoints because sleep patterns differ substantially during pregnancy and postpartum: <br>1. Pregnancy endpoint is ISI measured five weeks after baseline.<br>2. Postpartum endpoint is the average score of the ISI measures across 3, 6, and 12 months postpartum representing overall symptom burden.]