Impact of insomnia treatment on mood, brain function and cardiovascular health

Not Applicable

Completed

• Conditions: Chronic insomnia; Mental and Behavioural Disorders

• Registration Number: ISRCTN13983243
• Lead Sponsor: Concordia University

Brief Summary

2022 Results article in https://doi.org/10.1016/j.sleep.2022.05.010 (added 27/09/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-13
• Study Completion: 2020-07-14
• Last Update Posted: 10 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Meeting diagnostic criteria for chronic insomnia for at least 6 months
2. Aged 18 years or older

Exclusion Criteria

1. Current neurological disorder
2. Past history of brain lesion
3. Major surgery requiring general anaesthesia in the past 3 months
4. Untreated thyroid disorder
5. Chronic pain syndrome self-reported as interfering with sleep
6. Recent and severe infection in the past 3 months (e.g. pneumonia, kidney infection)
7. Active cancer or treated cancer with post-cancer treatment for less than 2 years
8. Stroke
9. Myocardial infarction
10. Arterial bypass or angioplasty (e.g. coronary, carotid, femoral)
11. Pacemaker
12. Heart failure causing limitation of ordinary physical activity
13. Renal insufficiency
14. Sleep apnea with an apnea-hypopnea index greater than 15/h
15. Restless legs syndrome with symptoms occurring on 3 or more days per week (based on Restless Legs Syndrome Rating Scale)
16. Periodic limb movements during sleep with index greater than 15/h during polysomnography
17. REM sleep behaviour disorder with more than 1 episode per month (based on polysomnography)
18. Narcolepsy with cataplexy (based on Ullanlinna Narcolepsy Scale)
19. Sleepwalking more than once per month
20. Having worked on night shifts or rotating shifts for more than 2 weeks in the last 3 months, or expecting to do so during the study period
21. Poor cognitive function (diagnosed with dementia and/or Montreal Cognitive Assessment (MoCA) less than 26)
22. Severe mental disorders:
22.1. Type I bipolar disorder
22.2. Schizophrenia
22.3. Anxiety disorders other than generalised anxiety disorder, except if associated with major depressive disorder (MDD)
22.4. Current substance use disorder
22.5. Current post-traumatic stress disorder
23. Current suicidality
24. Frequency alcohol consumption (more than 10 glasses per week)
25. Use of illicit drugs (more than once per month)
26. Pregnant or breastfeeding
27. Current psychotherapy or past cognitive behavioural therapy for insomnia
28. Unable to stop hypnosedative medications for at least 2 weeks prior to the first assessment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> The following are assessed at the baseline, post-treatment/post-waiting period and 12 month follow up:<br> 1. Self-reported insomnia symptoms, assessed using the following, both of which are completed using online questionnaires:<br> 1.1. Insomnia Severity Index (ISI)<br> 1.2. 14-day sleep diary (sleep efficacy measure) based on the Consensus Sleep Diary<br> 2. Physiological hyperarousal, assessed using the following:<br> 2.1. Heart rate variability, measured using electrocardiogram leads<br> 2.2. Sleep spindles, measured using electroencephalography leads during polysomnography<br> 3. Emotional hyperarousal, assessed using the UCLA Life Stress Interview and a daily stress diary, completed conjointly with the sleep diary (1.2.)<br>