UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062909 |
|---|---|
| Receipt number | R000072027 |
| Scientific Title | Effect of Repeated Subcutaneous NAD+ Injection on Sleep Quality Stratified by Baseline Sleep Status: A Single-Center Prospective Observational Study |
| Date of disclosure of the study information | 2026/09/15 |
| Last modified on | 2026/09/14 10:21:20 |
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Basic information
Public title
Effect of Repeated Subcutaneous NAD+ Injection on Sleep Quality
Acronym
NAD+ Sleep Study
Scientific Title
Effect of Repeated Subcutaneous NAD+ Injection on Sleep Quality Stratified by Baseline Sleep Status: A Single-Center Prospective Observational Study
Scientific Title:Acronym
NAD+ Sleep Quality Observational Study
Region
| Japan |
Condition
Condition
Sleep disturbance
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether repeated subcutaneous NAD+ injection differentially affects sleep quality according to baseline sleep status.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Change in PSQI (Pittsburgh Sleep Quality Index, modified version) Global Score from pre-dose to post-dose (Day1, Day3, Day7) of each course
Key secondary outcomes
Change in PSQI Question 6 (subjective sleep quality) score over time; Adverse events graded according to CTCAE v5.0
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Subcutaneous injection of 200 mg NAD+ dissolved in normal saline with lidocaine, administered to the abdomen or buttock, once every 2 weeks for three courses (6 weeks of total dosing).
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adults aged 20 to 79 years with a self-reported sleep complaint (a non-symptomatic comparison subgroup was also enrolled following an ethics-committee-approved protocol amendment)
Key exclusion criteria
Severe hepatic impairment; pregnancy or breastfeeding; history of serious psychiatric illness; use of NMN or NAD+ within 1 month prior to enrollment.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ryoki |
| Middle name | |
| Last name | Ohinata |
Organization
Ohinata Clinic
Division name
Department of Internal Medicine
Zip code
0200114
Address
2-9-9 Takamatsu, Morioka-shi, Iwate, Japan
TEL
0196625530
oohinataiin@gmail.com
Public contact
Name of contact person
| 1st name | Ryoki |
| Middle name | |
| Last name | Ohinata |
Organization
Ohinata Clinic
Division name
Department of Internal Medicine
Zip code
0200114
Address
2-9-9 Takamatsu, Morioka-shi, Iwate, Japan
TEL
08033159967
Homepage URL
oohinataiin@gmail.com
Sponsor or person
Institute
Ohinata Clinic
Institute
Department
Personal name
Ohinata Clinic
Funding Source
Organization
Ohinata Clinic
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ohinata Clinic
Address
2-9-9 Takamatsu, Morioka-shi, Iwate, Japan
Tel
08033159967
oohinataiin@gmail.com
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
| 2026 | Year | 09 | Month | 15 | 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
20
Results
The symptomatic group (baseline PSQI Global Score >5, n=10) showed significantly greater improvement in sleep quality after NAD+ administration compared with the non-symptomatic group (n=10) (change from baseline to Day1 of Course 1: -3.8 vs -1.2 points, t-test p=0.0018). No serious adverse events occurred.
Results date posted
| 2026 | Year | 09 | Month | 14 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The manuscript is currently under preparation for submission to a peer-reviewed journal.
Date of the first journal publication of results
Baseline Characteristics
Twenty adults (14 women, 6 men), mean age 52.3 years (SD 10.9), mean BMI 22.2 (SD 3.4).
Participant flow
All 20 enrolled participants completed all three courses of dosing and observation; there were no dropouts.
Adverse events
Seventeen adverse events were reported via free text (Grade 1: 11 events; Grade 2: 6 events); no serious adverse events occurred.
Outcome measures
Primary outcome: PSQI Global Score. Secondary outcome: PSQI Question 6 score alone.
Plan to share IPD
Data are available from the corresponding author upon reasonable request.
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 16 | Day |
Date of closure to data entry
| 2026 | Year | 01 | Month | 16 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 14 | Day |
Last modified on
| 2026 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072027
