UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060029 |
|---|---|
| Receipt number | R000068653 |
| Scientific Title | An Investigation into the Variability of Sleep-Wake Pattern Disruptions in Circadian Rhythm Sleep-Wake Disorders |
| Date of disclosure of the study information | 2025/12/09 |
| Last modified on | 2025/12/09 16:47:57 |
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Basic information
Public title
An Investigation into the Variability of Sleep-Wake Pattern Disruptions in Circadian Rhythm Sleep-Wake Disorders
Acronym
An Investigation into the Variability of Sleep-Wake Pattern Disruptions in Circadian Rhythm Sleep-Wake Disorders
Scientific Title
An Investigation into the Variability of Sleep-Wake Pattern Disruptions in Circadian Rhythm Sleep-Wake Disorders
Scientific Title:Acronym
An Investigation into the Variability of Sleep-Wake Pattern Disruptions in Circadian Rhythm Sleep-Wake Disorders
Region
| Japan |
Condition
Condition
Circadian Rhythm Sleep-Wake Disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Delayed Sleep-Wake Phase Disorder (DSWPD), a major subtype of Circadian Rhythm Sleep-Wake Disorders (CRSWDs), causes difficulty aligning internal rhythms with the 24-hour schedule, leading to delayed sleep onset, difficulty awakening, and severe social maladaptation in adolescents and young adults. Traditionally, DSWPD was thought to involve a delayed melatonin rhythm along with the sleep-wake phase. However, recent studies report that nearly half of patients show normal melatonin timing. We have observed variable sleep duration and unusually long circadian periods in patients with rhythm misalignment. This study retrospectively examines sleep diaries or actigraphy for psychiatric comorbidities and mood variability, and prospectively monitors sleep-wake patterns, melatonin rhythms, and estimated core body temperature rhythms. We aim to clarify concordance or discrepancy between behavioral and central clock rhythms and their relationship with slow-wave sleep profiles.
Basic objectives2
Others
Basic objectives -Others
In the retrospective study, past sleep diaries or actigraphy records will be collected to examine the presence of comorbid psychiatric disorders and associations with mood variability, using descriptive methods to identify clinical characteristics. In the prospective study, participants will complete secondary questionnaires and record sleep diaries and actigraphy for as long as feasible. At two arbitrary time points during the study period, circadian rhythms will be continuously monitored for at least two weeks using a device that estimates core body temperature from surface temperature. Home-based assessments of melatonin and cortisol rhythms will also be conducted. The interval between the first and second measurements of core body temperature and melatonin-cortisol rhythms will be within 2-4 weeks, and no longer than 5 weeks.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Melatonin and Cortisol Levels at Baseline and 2-4 Weeks Later, and Core Body Temperature
Key secondary outcomes
MEQ (Morningness-Eveningness Questionnaire)
MCTQ (Munich ChronoType Questionnaire)
Severity Level Criteria for Delayed Sleep Phase Syndrome
BDI (Beck Depression Inventory)
ESS (Epworth Sleepiness Scale)
HAM-D (Hamilton Depression Rating Scale)
Symptom Scale for Circadian Rhythm Sleep-Wake Disorders
Sleep Diary and Actigraphy
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 12 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The study will include patients attending the Sleep Clinic of the Department of Psychiatry at Fujita Health University who have CRSWDs or psychiatric disorders presenting with disturbed sleep-wake rhythms, and who have shown either fluctuations in sleep duration during the course of illness or circadian sleep-wake cycles longer than 24 hours. For the prospective study, participants must provide written informed consent after receiving a full explanation and demonstrating sufficient understanding. At the time of consent, patients must be aged 12 years or older (at least elementary school graduate) and younger than 70 years, and participation must be entirely voluntary.
Key exclusion criteria
1. Patients presenting with severe suicidal ideation
2. Patients deemed inappropriate by the principal investigator or co-investigators for any other reason
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Kitajima |
Organization
Fujita Health University
Division name
Department of Psychiatry, School of Medicine
Zip code
470-1192
Address
98 Dengakuge-kubo, Kutsukake-cho, Toyoake-shi, Aichi 470-1101, Japan
TEL
0562-93-2000
tsuyoshi@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Kumagai |
Organization
Fujita Health University
Division name
Department of Psychiatry, School of Medicine
Zip code
4701192
Address
98 Dengakuge-kubo, Kutsukake-cho, Toyoake-shi, Aichi 470-1101, Japan
TEL
0562-93-2000
Homepage URL
kumaniax@gmail.com
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Kumagai Reiko
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office of Research Support, Research Promotion Headquarters, Research Support Division, Secretariat of the Medical Research Ethics Committee, Fujita Health University
Address
98 Dengakuge-kubo, Kutsukake-cho, Toyoake-shi, Aichi 470-1101, Japan
Tel
0562-93-2865
f-irb@fujita-hu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
On the day of consent, participants will complete questionnaires as secondary outcome measures and record sleep diaries and actigraphy for as long as feasible. At two arbitrary time points during the study period, circadian rhythms will be continuously monitored for at least two weeks using a device that estimates core body temperature from surface temperature. The device will be attached to the abdomen using a dedicated sheet or band. Home-based assessment of melatonin and cortisol rhythms will also be performed: in a dim-light environment at home, saliva samples will be collected every hour from six hours before the expected bedtime until just before sleep, and once after waking the next morning, using a saliva collection kit. Participants will place a cotton swab in the mouth for three minutes to absorb saliva, which will then be analyzed for melatonin and cortisol concentrations using the ELISA method. The interval between the first and second measurements of core body temperature and melatonin-cortisol rhythms will be within 2-4 weeks, and no longer than 5 weeks.
Management information
Registered date
| 2025 | Year | 12 | Month | 09 | Day |
Last modified on
| 2025 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068653
