DepressionNCT06233422
Longitudinal Ecological Study on Sleep-Wake Patterns in MDD Using Actigraphy
An observational study of Depression and Sleep Disorders, Circadian Rhythm, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Sleep Disorders, Circadian Rhythm
- How many people
- 140 participants
- Where
- 1 siteHong Kong
- Study dates
- Jun 2024to Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample, if recruitment in the community is insufficient, we will recruit participants from our collaborating outpatient clinics, non-governmental organizations, and community centers
Who may be able to join
- 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.
Who cannot join
- 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
Show all 20Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Associations Between Actigraphy-Derived Sleep-Wake Patterns and Illness Trajectories and Treatment Response in Major Depressive Disorder
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.
- Conditions
- Depression, Sleep Disorders, Circadian Rhythm
- Being tested
- No intervention involved
- Keywords
- Actigraphy, Transdiagnostic Intervention, Depression, Rest-Activity Rhythm
- Medical subject headings
- Depression, Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention involvedOther
No intervention involved
| Study group | Role | What they receive |
|---|---|---|
| Major Depressive Disorder (MDD) Group | 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. Receives: Other: No intervention involved | |
| Healthy Control Group | 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. Receives: Other: No intervention involved |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 at baseline, 4 weekly assessment across study 1, and 1 at the end of study 1
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.
Measured: 24-hour wear time for 4 consecutive weeks
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.
Measured: 24-hour wear time for 4 consecutive weeks
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.
Measured: 24-hour wear time for 4 consecutive weeks
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.
Measured: 24-hour wear time for 4 consecutive weeks
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.
Measured: 24-hour wear time for 4 consecutive weeks
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.
Measured: 24-hour wear time for 4 consecutive weeks
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.
Measured: 24-hour wear time for 4 consecutive weeks
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.
Measured: 24-hour wear time for 4 consecutive weeks
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.
Measured: 24-hour wear time for 4 consecutive weeks
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.
Measured: 24-hour wear time for 4 consecutive weeks
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.
Measured: 24-hour wear time for 4 consecutive weeks
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.
Measured: 24-hour wear time for 4 consecutive weeks
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.
Measured: 24-hour wear time for 4 consecutive weeks
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,
Measured: 24-hour wear time for 4 consecutive weeks
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.
Measured: 24-hour wear time for 4 consecutive weeks
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.
Measured: 24-hour wear time for 4 consecutive weeks
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.
Measured: 24-hour wear time for 4 consecutive weeks
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.
Measured: 24-hour wear time for 4 consecutive weeks
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.
Measured: 24-hour wear time for 4 consecutive weeks
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.
Measured: 24-hour wear time for 4 consecutive weeks
Secondary outcomes (7)
Change in Hospital Anxiety and Depression Scale (HADS)
A 14-item scale measuring anxiety and depression in both hospital and community settings.
Measured: 1 at baseline, and 1 at the end of study 1
Change in Insomnia Severity Index (ISI)
A 7-item scale used to assess the perceived severity of insomnia.
Measured: 1 at baseline, and 1 at the end of study 1
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.
Measured: 1 at baseline, 4 weekly assessment across study 1, and 1 at the end of study 1
Change in Multidimensional Fatigue Inventory (MFI)
A 20-item scale used to assess five dimensions of fatigue.
Measured: 1 at baseline, and 1 at the end of study 1
Change in Short Form (6-Dimension) Health Survey (SF-6D)
A health survey used for measuring the quality of life on six dimensions.
Measured: 1 at baseline, and 1 at the end of study 1
Change in Sheehan Disability Scale (SDS)
A 5-item scale used to assess functional impairments in work/ school, social life, and family life.
Measured: 1 at baseline, and 1 at the end of study 1
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.
Measured: 4-week daily survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study startJun 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fiona YY Ho, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233422
- Sponsor's protocol ID
- PSY033
- Status last verified
- May 2024
- First submitted
- 14 Jan 2024
- Last updated
- 22 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between Actigraphy-Derived Sleep-Wake Patterns and Illness Trajectories and Treatment Response in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT06233422
- Acronym / sponsor ID
- PSY033
- Conditions
- Depression, Sleep Disorders, Circadian Rhythm
- Keywords
- Actigraphy, Transdiagnostic Intervention, Depression, Rest-Activity Rhythm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Major Depressive Disorder (MDD) Group | – | Other: No intervention involvedMDD 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 | – | Other: No intervention involvedHealthy 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample, if recruitment in the community is insufficient, we will recruit participants from our collaborating outpatient clinics, non-governmental organizations, and community centers
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
- Adults aged 18-65 years living in Hong Kong
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention involvedNo intervention involved | Other | Healthy Control Group, Major Depressive Disorder (MDD) Group |
Primary outcome
Change in Patient Health Questionnaire-9 (PHQ-9)
Time frame: 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.) - sleep onset latency (SOL)
Time frame: 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)
Time frame: 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.) - total sleep time (TST)
Time frame: 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.
Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - sleep efficiency (SE)
Time frame: 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.) - fragmentation index (FI)
Time frame: 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.
Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - time in bed (TIB)
Time frame: 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.
Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - number of awakenings (NOA)
Time frame: 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 - interdaily stability (IS)
Time frame: 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 non-parametric approach - intradaily variability (IV)
Time frame: 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 - relative amplitude (RA)
Time frame: 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 - the least active 5 hours (L5)
Time frame: 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 non-parametric approach - the most active 10 hours (M10)
Time frame: 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 - amplitude
Time frame: 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 - mesor
Time frame: 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
Time frame: 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.
Variability in sleep-wake variables using extended cosinor approach - up-mesor
Time frame: 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.
Variability in sleep-wake variables using extended cosinor approach - down-mesor
Time frame: 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 - alpha
Time frame: 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
Time frame: 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.
Variability in sleep-wake variables using extended cosinor approach - pseudo F-statistic
Time frame: 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.
7 secondary outcomes
Change in Hospital Anxiety and Depression Scale (HADS)
Time frame: 1 at baseline, and 1 at the end of study 1
Change in Insomnia Severity Index (ISI)
Time frame: 1 at baseline, and 1 at the end of study 1
Change in Patient-Reported Outcomes Measurement Information System-Sleep Disturbance (PROMIS-SD) and Sleep-Related Impairment (PROMIS-SRI)
Time frame: 1 at baseline, 4 weekly assessment across study 1, and 1 at the end of study 1
Change in Multidimensional Fatigue Inventory (MFI)
Time frame: 1 at baseline, and 1 at the end of study 1
Change in Short Form (6-Dimension) Health Survey (SF-6D)
Time frame: 1 at baseline, and 1 at the end of study 1
Change in Sheehan Disability Scale (SDS)
Time frame: 1 at baseline, and 1 at the end of study 1
Change in Core Consensus Standardized Sleep Diary
Time frame: 4-week daily survey
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Sleep Disorders, Circadian Rhythm, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Health Questionnaire-9 (PHQ-9) (time frame: 1 at baseline, 4 weekly assessment across study 1, and 1 at the end of study 1). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.