Longitudinal Ecological Study on Sleep-Wake Patterns in MDD Using Actigraphy

Not yet recruiting

• Conditions: Depression; Sleep Disorders, Circadian Rhythm
• Interventions: Other: No intervention involved

• Registration Number: NCT06233422
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

The proposed study will include a longitudinal ecological study (Study 1) and a randomised controlled trial (Study 2). The aims will be to (1) identify the sleep-wake profiles in individuals with Major Depressive Disorder (MDD) through clustering; (2) examine the associations between sleep-wake features/profiles and the prognosis of MDD; and (3) investigate the anti-depressant effects of sleep- and circadian-targeted intervention in those with MDD and whether sleep-wake features/profiles may moderate the treatment outcomes.

In Study 1, a total of 140 participants comprising 70 participants with MDD and 70 age- and gender-matched healthy controls will be recruited. Sleep-wake patterns will be collected for 4 consecutive weeks using actigraphy devices and one-off self-report measures will be collected via an in-house smartphone application, PsyHub.

Study 1 and 2 will follow the CONSORT and STROBE guidelines, respectively. The current registration is only for Study 1 of the current research project.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-14
• Study First Submitted QC: 2024-01-30
• Study First Posted: 2024-01-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-22
• Study Start: 2024-06
• Primary Completion: 2025-10
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Major Depressive Disorder (MDD) Group	No intervention involved	MDD group will consist of 70 participants with MDD, aged between 18-65, with a Patient Health Questionnaire-9 (PHQ-9) score of at least 10; who are also experiencing at least 1 sleep or circadian problem in the past 3 months.
Healthy Control Group	No intervention involved	Healthy control group will consist of 70 healthy control participants, aged between 18-65, with a Patient Health Questionnaire-9 (PHQ-9) score of below 5, indicating minimal or no depressive symptoms.

Primary Outcome Measures

Name	Time	Method
Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - time in bed (TIB)	24-hour wear time for 4 consecutive weeks	Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, TIB is one of the sleep parameters which will be measured by Actigraphy.
Variability in sleep-wake variables using extended cosinor approach - down-mesor	24-hour wear time for 4 consecutive weeks	Rhythm timing (down-mesor) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. This tells the time of activity offset.
Variability in sleep-wake variables using extended cosinor approach - pseudo F-statistic	24-hour wear time for 4 consecutive weeks	Rhythm robustness (pseudo F-statistic) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. This tells the goodness of extended cosine fit.
Change in Patient Health Questionnaire-9 (PHQ-9)	1 at baseline, 4 weekly assessment across study 1, and 1 at the end of study 1	A 9-item questionnaire used for screening, diagnosing, and monitoring the severity of depression, by scoring each item from "0" (not at all) to "3" (nearly everyday), total severity scale ranging from 0 to 27.
Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - total sleep time (TST)	24-hour wear time for 4 consecutive weeks	Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, TST is one of the sleep parameters which will be measured by Actigraphy.
Variability in sleep-wake variables using non-parametric approach - relative amplitude (RA)	24-hour wear time for 4 consecutive weeks	RA is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the non-parametric approach.
Variability in sleep-wake variables using non-parametric approach - interdaily stability (IS)	24-hour wear time for 4 consecutive weeks	IS is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the non-parametric approach.
Variability in sleep-wake variables using extended cosinor approach - mesor	24-hour wear time for 4 consecutive weeks	Rhythm height (mesor) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. This tells the 24-hour adjusted mean rhythm activity,
Variability in sleep-wake variables using extended cosinor approach - acrophase	24-hour wear time for 4 consecutive weeks	Rhythm timing (acrophase) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. It tells the time of peak rhythm activity.
Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - sleep onset latency (SOL)	24-hour wear time for 4 consecutive weeks	Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, SOL is one of the sleep parameters which will be measured by Actigraphy.
Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - wake after sleep onset (WASO)	24-hour wear time for 4 consecutive weeks	Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, WASO is one of the sleep parameters which will be measured by Actigraphy.
Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - sleep efficiency (SE)	24-hour wear time for 4 consecutive weeks	Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, SE is one of the sleep parameters which will be measured by Actigraphy.
Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - number of awakenings (NOA)	24-hour wear time for 4 consecutive weeks	Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, NOA is one of the sleep parameters which will be measured by Actigraphy.
Variability in sleep-wake variables using non-parametric approach - the least active 5 hours (L5)	24-hour wear time for 4 consecutive weeks	L5 is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the non-parametric approach.
Variability in sleep-wake variables using extended cosinor approach - amplitude	24-hour wear time for 4 consecutive weeks	Rhythm height (amplitude) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. It tells the difference between the peak and nadir of the rhythm.
Variability in sleep-wake variables using extended cosinor approach - up-mesor	24-hour wear time for 4 consecutive weeks	Rhythm timing (up-mesor) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. This tells the activity initiation time.
Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - fragmentation index (FI)	24-hour wear time for 4 consecutive weeks	Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, FI is one of the sleep parameters which will be measured by Actigraphy.
Variability in sleep-wake variables using non-parametric approach - intradaily variability (IV)	24-hour wear time for 4 consecutive weeks	IV is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the non-parametric approach.
Variability in sleep-wake variables using non-parametric approach - the most active 10 hours (M10)	24-hour wear time for 4 consecutive weeks	M10 is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the non-parametric approach.
Variability in sleep-wake variables using extended cosinor approach - alpha	24-hour wear time for 4 consecutive weeks	Rhythm shape (alpha) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. This tells the width of the rhythm.
Variability in sleep-wake variables using extended cosinor approach - beta	24-hour wear time for 4 consecutive weeks	Rhythm shape (beta) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. It tells the steepness of the fitted curve.

Secondary Outcome Measures

Name	Time	Method
Change in Multidimensional Fatigue Inventory (MFI)	1 at baseline, and 1 at the end of study 1	A 20-item scale used to assess five dimensions of fatigue.
Change in Insomnia Severity Index (ISI)	1 at baseline, and 1 at the end of study 1	A 7-item scale used to assess the perceived severity of insomnia.
Change in Sheehan Disability Scale (SDS)	1 at baseline, and 1 at the end of study 1	A 5-item scale used to assess functional impairments in work/ school, social life, and family life.
Change in Core Consensus Standardized Sleep Diary	4-week daily survey	A 9-item scale used to record sleep time, wake time, perceived sleeping quality, and use of hypnotics.
Change in Short Form (6-Dimension) Health Survey (SF-6D)	1 at baseline, and 1 at the end of study 1	A health survey used for measuring the quality of life on six dimensions.
Change in Patient-Reported Outcomes Measurement Information System-Sleep Disturbance (PROMIS-SD) and Sleep-Related Impairment (PROMIS-SRI)	1 at baseline, 4 weekly assessment across study 1, and 1 at the end of study 1	8-item scales to assess sleep and circadian functions.
Change in Hospital Anxiety and Depression Scale (HADS)	1 at baseline, and 1 at the end of study 1	A 14-item scale measuring anxiety and depression in both hospital and community settings.

Trial Locations

Locations (1)

The Chinese University of Hong Kong; 🇭🇰 Sha Tin, Hong Kong