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

Depression Clinical Trial

Official title:

Associations Between Actigraphy-Derived Sleep-Wake Patterns and Illness Trajectories and Treatment Response in Major Depressive Disorder

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06233422
• Other study ID #: PSY033
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: January 2026

Study information

• Verified date: May 2024
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: January 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria for Healthy Control Group:

• Adults aged 18 to 65 years living in Hong Kong

• Being fluent and literate in Cantonese

• A Patient Health Questionnaire-9 (PHQ-9) score of below 5, indicating minimal or no depressive symptoms

• Accessibility to an Internet-enabled mobile device (iOS or Android operating system)

• Willingness to provide informed consent and comply with the trial protocol.

Exclusion Criteria for Healthy Control Group:

• Presence of any psychiatric disorder(s) as assessed by MINI

• Shift work, pregnancy, or work, family, or other commitments that interfere with regular sleep-wake patterns

• Presence of other untreated sleep disorders based on cut-off scores of individual sections in SLEEP-50.

We will not exclude those with current suicidal risks (i.e., non-fleeting intent or plan), which is a common symptom of MDD. However, if serious suicidal risk (i.e., PHQ-9 Item 9 score > 2) is identified, the participant will be referred to the PI (a clinical psychologist) for further assessment and professional mental health services if deemed necessary.

Inclusion Criteria for the Major Depressive Disorder (MDD) group:

• Adults aged 18-65 years living in Hong Kong

• Being fluent and literate in Cantonese

• A PHQ-9 score of at least 10, indicating a moderate level of depression.

• Meeting the DSM diagnostic criteria for current MDD according to the Mini International Neuropsychiatric Interview (MINI)

• Experiencing = 1 sleep or circadian problem in the past 3 months according to the sleep and circadian problems checklist (i.e., time needed to fall asleep = 30 minutes, wake after sleep onset = 30 minutes, < 6-hour sleep per night or = 9-hour sleep per night per 24-hour period, and falling asleep after 2:00 AM = 3 nights per week; and variability in the sleep-wake schedule = 2.78 hours within a week)

• Access to an Internet-enabled mobile device (iOS or Android operating system)

• Willingness to provide informed consent and comply with the trial protocol.

Exclusion Criteria for the Major Depressive Disorder (MDD) group:

• Severe medical or neurocognitive disorder(s) that make participation unsuitable based on the team's clinical experience

• Presence of other psychiatric disorders as assessed by MINI

• A history of electroconvulsive therapy (ECT)

• Current involvement in any psychological treatment programme that targets depression and/or sleep and circadian problems

• A change in the class or dose of any prescribed psychotropic drugs within 6 weeks before the baseline assessment

• Shift work, pregnancy, or work, family, or other commitments that interfere with regular sleep-wake patterns

• Presence of other untreated sleep disorders, including narcolepsy, obstructive sleep apnoea (OSA), and restless leg syndrome (RLS)/periodic leg movement disorder (PLMD) based on the cut-off scores of SLEEP-50 (narcolepsy = 7; OSA = 15; RLS/PLMD = 7)

Related Conditions & MeSH terms

• Depression
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders

Intervention

Other:
• No intervention involved
No intervention involved

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Sha Tin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Patient Health Questionnaire-9 (PHQ-9)	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.	1 at baseline, 4 weekly assessment across study 1, and 1 at the end of study 1
Primary	Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - sleep onset latency (SOL)	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.	24-hour wear time for 4 consecutive weeks
Primary	Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - wake after sleep onset (WASO)	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.	24-hour wear time for 4 consecutive weeks
Primary	Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - total sleep time (TST)	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.	24-hour wear time for 4 consecutive weeks
Primary	Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - sleep efficiency (SE)	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.	24-hour wear time for 4 consecutive weeks
Primary	Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - fragmentation index (FI)	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.	24-hour wear time for 4 consecutive weeks
Primary	Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - time in bed (TIB)	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.	24-hour wear time for 4 consecutive weeks
Primary	Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - number of awakenings (NOA)	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.	24-hour wear time for 4 consecutive weeks
Primary	Variability in sleep-wake variables using non-parametric approach - interdaily stability (IS)	IS is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the non-parametric approach.	24-hour wear time for 4 consecutive weeks
Primary	Variability in sleep-wake variables using non-parametric approach - intradaily variability (IV)	IV is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the non-parametric approach.	24-hour wear time for 4 consecutive weeks
Primary	Variability in sleep-wake variables using non-parametric approach - relative amplitude (RA)	RA is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the non-parametric approach.	24-hour wear time for 4 consecutive weeks
Primary	Variability in sleep-wake variables using non-parametric approach - the least active 5 hours (L5)	L5 is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the non-parametric approach.	24-hour wear time for 4 consecutive weeks
Primary	Variability in sleep-wake variables using non-parametric approach - the most active 10 hours (M10)	M10 is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the non-parametric approach.	24-hour wear time for 4 consecutive weeks
Primary	Variability in sleep-wake variables using extended cosinor approach - amplitude	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.	24-hour wear time for 4 consecutive weeks
Primary	Variability in sleep-wake variables using extended cosinor approach - mesor	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,	24-hour wear time for 4 consecutive weeks
Primary	Variability in sleep-wake variables using extended cosinor approach - acrophase	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.	24-hour wear time for 4 consecutive weeks
Primary	Variability in sleep-wake variables using extended cosinor approach - up-mesor	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.	24-hour wear time for 4 consecutive weeks
Primary	Variability in sleep-wake variables using extended cosinor approach - down-mesor	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.	24-hour wear time for 4 consecutive weeks
Primary	Variability in sleep-wake variables using extended cosinor approach - alpha	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.	24-hour wear time for 4 consecutive weeks
Primary	Variability in sleep-wake variables using extended cosinor approach - beta	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.	24-hour wear time for 4 consecutive weeks
Primary	Variability in sleep-wake variables using extended cosinor approach - pseudo F-statistic	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.	24-hour wear time for 4 consecutive weeks
Secondary	Change in Hospital Anxiety and Depression Scale (HADS)	A 14-item scale measuring anxiety and depression in both hospital and community settings.	1 at baseline, and 1 at the end of study 1
Secondary	Change in Insomnia Severity Index (ISI)	A 7-item scale used to assess the perceived severity of insomnia.	1 at baseline, and 1 at the end of study 1
Secondary	Change in Patient-Reported Outcomes Measurement Information System-Sleep Disturbance (PROMIS-SD) and Sleep-Related Impairment (PROMIS-SRI)	8-item scales to assess sleep and circadian functions.	1 at baseline, 4 weekly assessment across study 1, and 1 at the end of study 1
Secondary	Change in Multidimensional Fatigue Inventory (MFI)	A 20-item scale used to assess five dimensions of fatigue.	1 at baseline, and 1 at the end of study 1
Secondary	Change in Short Form (6-Dimension) Health Survey (SF-6D)	A health survey used for measuring the quality of life on six dimensions.	1 at baseline, and 1 at the end of study 1
Secondary	Change in Sheehan Disability Scale (SDS)	A 5-item scale used to assess functional impairments in work/ school, social life, and family life.	1 at baseline, and 1 at the end of study 1
Secondary	Change in Core Consensus Standardized Sleep Diary	A 9-item scale used to record sleep time, wake time, perceived sleeping quality, and use of hypnotics.	4-week daily survey