The Effects of Insomnia Treatment on Overnight Regulation of Emotional Memories and Risk for Mental Disorders

Not Applicable

Not yet recruiting

• Conditions: Insomnia Chronic; Depression, Anxiety

• Registration Number: NCT06567210
• Lead Sponsor: Woolcock Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-7-18
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Diagnosis of insomnia disorder (DSM-V-TR) or ISI score = 10.<br><br> - All sexes and genders.<br><br> - Between 25 and 45 years of age.<br><br> - Able to provide informed consent.<br><br> - Proficient in English.<br><br>Exclusion Criteria:<br><br> - Sleep or circadian disorder other than insomnia (e.g., hypersomnolence, periodic<br> limb movement disorder, advanced or delayed sleep phase disorder, moderate to severe<br> sleep apnoea disorder based on previous sleep study with an apnea-hypopnea index =<br> 15 and/or STOP-BANG high-risk score and/or finger-pulse oximetry oxygen desaturation<br> index (ODI) = 10).<br><br> - Any contradictions for MRI (e.g., claustrophobia, presence of metal in body,<br> cochlear implants).<br><br> - Current or history of neurological disorders (e.g., stroke, brain injury).<br><br> - Current or history of any disorder listed in DSM-V other than major depression and<br> anxiety disorders (post-traumatic stress disorder is excluded).<br><br> - Centrally active agents or presence of medical condition that may affect<br> participation.<br><br> - Pregnancy or actively trying to conceive, or lactating.<br><br> - Shift work for at least 2 shifts per week in the past 3 months (i.e., work between<br> 21:00 and 6:00).<br><br> - Travel across time zones over 3 hours difference in the previous 30 days (will<br> require a 1-week adjustment period per hour of time zone travelled).<br><br> - Unwilling to know about potential incidental findings.<br><br> - No consent or adherence to instructions for any part of the study protocol.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index (ISI) score;Patient Health Questionnaire-9 (PHQ-9) score;General Anxiety Disorder-7 (GAD-7) score

Secondary Outcome Measures

Name	Time	Method
EEG sleep efficiency (SE - %);EEG total sleep time (TST - minutes);EEG wake duration (minutes);EEG sleep onset latency (SOL - minutes);EEG sleep stages (%);Actigraphy sleep efficiency (%);Actigraphy total sleep duration (minutes);Actigraphy wake duration (minutes);Actigraphy sleep onset latency (minutes);7-days light exposure (lux);Hour of Dim-Light Melatonin Onset (HDLMO - hour);3-days distal-proximal skin-temperature gradients (DPG);Self-reported sleep duration (min);Self-reported wake duration (min);Self-reported sleep onset latency (min);Self-reported sleep quality (out of 5);Sleep misperception index (SPI - %)