UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045835 |
|---|---|
| Receipt number | R000051862 |
| Scientific Title | The study to understand and overcome psychiatric and neurological disorders from an investigation of rapid eye movement (REM) sleep. -The significance of decrease in REM sleep by an analysis of metabolomes in patients with obstructive sleep apnea before and following the treatment- |
| Date of disclosure of the study information | 2021/10/26 |
| Last modified on | 2025/05/02 15:34:47 |
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Basic information
Public title
The study to understand and overcome psychiatric and neurological disorders from an investigation of rapid eye movement (REM) sleep. -The significance of decrease in REM sleep by an analysis of metabolomes in patients with obstructive sleep apnea before and following the treatment-
Acronym
Understanding and overcoming psychiatric and neurological diseases with approaches from REM sleep
Scientific Title
The study to understand and overcome psychiatric and neurological disorders from an investigation of rapid eye movement (REM) sleep. -The significance of decrease in REM sleep by an analysis of metabolomes in patients with obstructive sleep apnea before and following the treatment-
Scientific Title:Acronym
Understanding and overcoming psychiatric and neurological diseases with approaches from REM sleep
Region
| Japan |
Condition
Condition
OSAS patients whose REM sleep duration is less than 12% of their total sleep duration measured by PSG
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It has become clear that there is a significant relationship between REM sleep and various kinds of psychiatric and neurological diseases. In addition, it is well known that REM sleep duration significantly decreases in patients with severe obstructive sleep apnea syndrome(OSAS), and substantial rebound in REM sleep duration is noted following the start of CPAP treatment. The aim of this study is to determine the effect of changes in REM sleep duration on brain homeostasis by analysis of blood metabolomes in patients with severe OSAS before and following CPAP treatment.
Basic objectives2
Others
Basic objectives -Others
To evaluate the total duration and the proportion of REM sleep, and sleep latency before and after CPAP treatment.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Investigation of specific metabolomes and their concentrations which would appear according to changes in REM sleep duration in patients with OSAS before and following CPAP treatment
Key secondary outcomes
Changes in REM sleep duration and ratio to total sleep duration in the patients with OSAS before and following CPAP treatment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Although tests are permitted under the health insurance system, to perform PSG several times for the participants (OSAS patients whose REM sleep duration is less than 12% to their total sleep duration)
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients with less than 10% of REM sleep identified by PSG
Key exclusion criteria
1. Patients who were already diagnosed with sleep apnea syndrome and treated.
2. Patients with hemodialysis
3. Patients with cancer
4. Patients on oxygen therapy
5. Patients with a cardiac pacemaker
6. Physically disabled patients
7. Patients who refuse to participate in this trial
8. Patients who are judged as inappropriate candidates by doctors
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Chin |
Organization
Nihon University of Medicine
Division name
Department of Sleep Medicine and Respiratory Care Division of Sleep Medicine Department of Internal Medicine
Zip code
173-8610
Address
30-1 Oyaguchi kami-cho, Itabashi-ku Tokyo
TEL
03-3972-8111
chin.kazuo@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Mamiko |
| Middle name | |
| Last name | Hoshi |
Organization
Graduate school of medicine, Nihon university
Division name
Respitory medicine
Zip code
173-8610
Address
30-1 Oyaguchi kami-cho, Itabashi-ku Tokyo
TEL
03-3972-8111
Homepage URL
mema21005@g.nihon-u.ac.jp
Sponsor or person
Institute
Nihon University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shinjuku Sleep and Respiratory Medicine Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University of Medicine
Address
30-1 Oyaguchi kami-cho, Itabashi-ku Tokyo
Tel
03-3972-8111
med.itabashi.chiken@nihon-u.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
| 2021 | Year | 10 | Month | 26 | 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
No significant side effect at April 24, 2024
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 22 | Day |
Last modified on
| 2025 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051862
