UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055990 |
|---|---|
| Receipt number | R000063990 |
| Scientific Title | Study on sleep pattern changes using Somnomat, A Rocking Bed, Providing Personalized Sleep Onset Routines |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2024/10/30 14:08:38 |
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Basic information
Public title
Study on sleep pattern changes using Somnomat, A Rocking Bed, Providing Personalized Sleep Onset Routines
Acronym
Study on sleep pattern changes using Somnomat, A Rocking Bed
Scientific Title
Study on sleep pattern changes using Somnomat, A Rocking Bed, Providing Personalized Sleep Onset Routines
Scientific Title:Acronym
Study on sleep pattern changes using Somnomat, A Rocking Bed
Region
| Japan |
Condition
Condition
Sleep-onset Insomnia (Initial Insomnia)
Classification by specialty
| Psychiatry | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the effectiveness of a combination of such environmental adjustment and vestibular stimulation (VS) during sleep induction in patients with hypnagogic insomnia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep onset latency
Key secondary outcomes
Sleep quality
Quality of life
Activity level
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Using the Somnomat through vestibular stimulation, warm light, and relaxing sounds, and personalized sleep hygiene routines
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
| 55 | years-old | < |
Age-upper limit
| 91 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Self-rated with Sleep-onset Insomnia (Initial Insomnia), experiencing difficulties initiating sleep with subjective sleep latency greater than 20-30 minutes.
Willingness to comply with the study protocol and interventions.
Ability to understand and provide informed consent.
Availability for the entire duration of the study (5 weeks).
No participation in any other similar sleep intervention studies concurrently.
To use the device safely, people with cognitive grade IIB or lower based on the criteria for determining the level of independence in daily life for elderly people with dementia.
Key exclusion criteria
Presence of other sleep disorders or medical conditions that significantly impact sleep (e.g., sleep apnea, restless legs syndrome).
Regular use of medications or substances known to affect sleep (excluding occasional use of over-the-counter sleep aids).
Check with facility staff to exclude individuals with significant psychiatric disorders or cognitive impairments that could interfere with study procedures or data collection.
Pregnant or nursing individuals.
Individuals with a history of vestibular disorders or conditions that might contraindicate vestibular stimulation.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Kato |
Organization
National Center for Geriatrics and Gerontology
Division name
Laboratory for Clinical Evaluation with Robotics, Assistive Robot Center
Zip code
4748511
Address
7-430, Morioka, Obu, Aichi, JAPAN
TEL
0562462311
kk0724@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Kato |
Organization
National Center for Geriatrics and Gerontology
Division name
Laboratory for Clinical Evaluation with Robotics, Assistive Robot Center
Zip code
4748511
Address
7-430, Morioka, Obu, Aichi, JAPAN
TEL
0562462311
Homepage URL
kk0724@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics and Conflict of interest Committee, National Center for Geriatrics and Gerontology
Address
7-430, Morioka, Obu, Aichi, JAPAN
Tel
0562462311
IRB@ncgg.go.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
１．ラ・プラス ヒルトップ（愛知県）
２．愛厚ホーム大府苑（愛知県）
３．フラワーサーチ大府（愛知県）
４．ラ・プラス 鶴が沢（愛知県）
５．ラ・プラス 青山（愛知県）
６．地域密着型複合施設 なごみの郷（愛知県）
７．特別養護老人ホーム まどかの郷（愛知県）
1. La Plus Hill Top, Nagoya, Aichi
2. Aikou-Home Obuen, Obu, Aichi
3. Flower Search Obu, Obu, Aichi
4. La Plus Tsurugaoka, Nagoya, Aichi
5. La Plus Aoyama, Nagoya, Aichi
6. Nagomi-no-Sato, Gamagori, Aichi
7. Madoka-no-Sato, Koda-cho, Nukata-gun, Aichi
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 01 | 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
| 2023 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | 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
Management information
Registered date
| 2024 | Year | 10 | Month | 30 | Day |
Last modified on
| 2024 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063990
