Cognition Disorders in Old AgeINSPIORNCT06135740
Impact of Nutrition, Sleep, and Physical Activity on Intellectual Function and Muscle Mass in Older Adults
A study testing Fitbit wearing, with notification for sleep, activity and nutrition based fitbit data and Routine care in people with Cognition Disorders in Old Age and Cognitive Function, run by Tokyo University at 1 site in Japan.
Trial summary
The goal of this prospective, single site, interventional randomized control trial is to treat age related health conditions in adults older than 65 years and functional independence. Read more about this study
- Who is it for?
- Ages 65 to 92 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition Disorders in Old Age, Cognitive Function, Frailty/Sarcopenia
- What is being tested?
- Fitbit wearing, with notification for sleep, activity and nutrition based fitbit data and Routine care
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 355 participants
- Where
- 1 siteJapan
- Study dates
- 8 Nov 2023to 31 Jul 2025
- Phase
- Interventional
- 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 65 to 92 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Over 65 years of age.
- Living in Japan.
- Living independently with or without carer support.
- Able and willing to wear a Fitbit for the duration of the study (≥20 hours a day, including during sleep).
- Individuals that are able and willing to receive and act on interventions.
- Has capacity to consent to inclusion in the study.
Show all 11Show fewer
- Smartphone access to allow Fitbit installation and setup.
- Has one or more of the following comorbidities:
- BMI <20 (65-69 years), <21.5 (≥70 years)
- Pre-frail or Frail: scoring 1-2 (pre-frail) or 3+ (frail) based on the FRAIL questionnaire
- Sarcopenia: low grip strength (female <18 kg, male <28 kg); Gait speed (< 1m/s); low Skeletal Muscle mass Index (female 5.7 kg/m2; male 7 kg/m2)
Who cannot join
- Individuals receiving full time care in a care facility.
- Individuals that are unable to receive and/or act on interventions.
- Individuals who are existing wearable users, or who have prior experience using a wearable to manage their health.
- Individuals with uncontrolled hypertension, diabetes, CKD or with cardiac pacemakers and/or cardiovascular stent(s).
- Individuals who have any additional condition or situation that the Investigator (PI) or designee determines as inappropriate for participation in this study.
- Individuals with no comorbidities as defined above.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Graduate School of Frontier Sciences, The University of Tokyo
Kashiwa, Chiba, 2778562
About this study
Official title: Impact of Notifications on Nutrition, Sleep, and Physical Activity on Intellectual Function and Muscle Mass in OldeR Adults (INSPIOR)
The goal of this prospective, single site, interventional randomized control trial is to treat age related health conditions in adults older than 65 years and functional independence. The main question of the study is to answer the effectiveness of notification on activity, sleep, and nutrition based on wearable device Fitbit recorded data for the improvement of health conditions including intellectual property and physical function, compared to usual care. Participants in the intervention arm will be given a Fitbit Charge 5 device and asked to wear this for the duration of the study, including during sleep. The study intervention will run for 6 months. Notifications will be issued using a monitoring software in Japanese, and issued automatically to participants. Participants in the control arm will be given a routine care and health-related information. Researchers will compare cognitive performance, muscle mass and physical activity between the two groups to see if the notification based on Fitbit data would promote the health conditions of older adults.
Read the detailed description
This is a prospective, single site, interventional randomized control trial. The primary purpose is to treat age related health conditions. The current study is nested within an established cohort based in Kashiwa City in Japan, which consists of older adults living independently. The inclusion criteria of this study is age equal to or older than 65 years and functional independence (i.e., not requiring nursing care provided by long-term care insurance). The investigators plan to conduct a randomized controlled trial to test the effectiveness of notification based on Fitbit recorded data, used to prompt health and wellness actions on a variety of health outcomes, compared to usual care. On enrollment, baseline demographic and health information as well as baseline measurements for quality of life, and physical and mental health, will be collected. Subsequently, the study intervention will run for 6 months. Participants in the intervention arm will be given a Fitbit Charge 5 device and asked to wear this for the duration of the study, including during sleep. Participants will receive sessions to teach them how to use the Charge 5 device and access the information produced. Those who meet the above criteria for intervention will receive automatically generated notifications that include lifestyle recommendations. Notifications will be issued using a monitoring software in Japanese, and issued automatically as text alerts to participants. Participants will receive encouraging notifications to promote adherence and health condition. Participants in the control arm will be given a routine care and health-related information. Participants who fail to exhibit a behavior change in the week following the alert, or who are not engaging with the study (e.g., by not wearing the Fitbit device) will be followed up by phone by a member of the community research group. Researchers will compare cognitive performance and physical activity between the two groups to see if the notification based on Fitbit data would promote the health conditions of older adults. Results of this trial will be valuable for informing further implementation of wearable devices and related digital devices in elderly populations in Japan and other countries in the region.
- Being tested
- Fitbit wearing, with notification for sleep, activity and nutrition based fitbit data, Routine care
- Medical subject headings
- Frailty, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit wearing, with notification for sleep, activity and nutrition based fitbit dataDevice
Notification on Nutrition, Sleep, and Physical Activity based on fitbit-based data, and Nutritional supplementation and Promotion of Exercise
Routine careDevice
Regular Care on sleep, activity and nutrition
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Notification on Nutrition, Sleep, and Physical Activity based on fitbit-based data Receives: Device: Fitbit wearing, with notification for sleep, activity and nutrition based fitbit data |
| Control | Sham comparator | Regular Care Receives: Device: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive function
TMT
Measured: 0 - 6 months
General Cognition
MoCA
Measured: 0 - 6 months
Muscle mass
Skeletal Muscle mass Index
Measured: 0 - 6 months
Secondary outcomes (2)
Amount of exercise
Step counts measured by fitbit
Measured: 0 - 6 months
Amount of sleep
Total sleep time measured by fitbit
Measured: 0 - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start8 Nov 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognition Disorders in Old AgeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokyo University
- Sponsor type
- University, hospital or other
- Collaborators
- Google LLC.
- Responsible party
- Principal investigator, Tatsuhiro Hisatsune, Tokyo University
- Investigators
- Tatsuhiro Hisatsune, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135740
- Sponsor's protocol ID
- 22-360
- Acronym
- INSPIOR
- Status last verified
- Apr 2026
- First submitted
- 13 Nov 2023
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sakurai K, Tanaka R, Ledsam J, Shiraishi I, Kasahara H, Anzai S, Watanabe M, Funakawa M, Shimada S, Goto T, Kawabata R, Murasakino K, Kawaura T, Inamura N, Kaneta K, Kobayashi S, Nomura T, Karasawa N, Matsumoto T, Taira T, Ishiguro T, Kudo K, Thompson MJ, Kayama H, Sugawara Y, Warisawa S, Hisatsune T. Effect of a wearable-based individualised multidomain lifestyle intervention on cognitive and physical function in older adults at risk of decline (INSPIOR): a single-centre, open-label, randomised controlled trial. EClinicalMedicine. 2026 Sep 23;100:104212. doi: 10.1016/j.eclinm.2026.104212. eCollection 2026 Oct.
PubMed 42831056
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Notifications on Nutrition, Sleep, and Physical Activity on Intellectual Function and Muscle Mass in OldeR Adults (INSPIOR)
- ClinicalTrials.gov ID
- NCT06135740
- Acronym / sponsor ID
- INSPIOR / 22-360
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Tokyo UniversityUniversity, hospital or other
- Collaborators
- Google LLC.
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 18 Nov 2023 (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 goal of this prospective, single site, interventional randomized control trial is to treat age related health conditions in adults older than 65 years and functional independence. The main question of the study is to answer the effectiveness of notification on activity, sleep, and nutrition based on wearable device Fitbit recorded data for the improvement of health conditions including intellectual property and physical function, compared to usual care. Participants in the intervention arm will be given a Fitbit Charge 5 device and asked to wear this for the duration of the study, including during sleep. The study intervention will run for 6 months. Notifications will be issued using a monitoring software in Japanese, and issued automatically to participants. Participants in the control arm will be given a routine care and health-related information. Researchers will compare cognitive performance, muscle mass and physical activity between the two groups to see if the notification based on Fitbit data would promote the health conditions of older adults.
Detailed description
This is a prospective, single site, interventional randomized control trial. The primary purpose is to treat age related health conditions. The current study is nested within an established cohort based in Kashiwa City in Japan, which consists of older adults living independently. The inclusion criteria of this study is age equal to or older than 65 years and functional independence (i.e., not requiring nursing care provided by long-term care insurance). The investigators plan to conduct a randomized controlled trial to test the effectiveness of notification based on Fitbit recorded data, used to prompt health and wellness actions on a variety of health outcomes, compared to usual care. On enrollment, baseline demographic and health information as well as baseline measurements for quality of life, and physical and mental health, will be collected. Subsequently, the study intervention will run for 6 months. Participants in the intervention arm will be given a Fitbit Charge 5 device and asked to wear this for the duration of the study, including during sleep. Participants will receive sessions to teach them how to use the Charge 5 device and access the information produced. Those who meet the above criteria for intervention will receive automatically generated notifications that include lifestyle recommendations. Notifications will be issued using a monitoring software in Japanese, and issued automatically as text alerts to participants. Participants will receive encouraging notifications to promote adherence and health condition. Participants in the control arm will be given a routine care and health-related information. Participants who fail to exhibit a behavior change in the week following the alert, or who are not engaging with the study (e.g., by not wearing the Fitbit device) will be followed up by phone by a member of the community research group. Researchers will compare cognitive performance and physical activity between the two groups to see if the notification based on Fitbit data would promote the health conditions of older adults. Results of this trial will be valuable for informing further implementation of wearable devices and related digital devices in elderly populations in Japan and other countries in the region.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Device: Fitbit wearing, with notification for sleep, activity and nutrition based fitbit dataNotification on Nutrition, Sleep, and Physical Activity based on fitbit-based data |
| Control | Sham comparator | Device: Routine careRegular Care |
Who may qualify
- Ages
- 65 to 92 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- Over 65 years of age.
- Living in Japan.
- Living independently with or without carer support.
- Able and willing to wear a Fitbit for the duration of the study (≥20 hours a day, including during sleep).
- Individuals that are able and willing to receive and act on interventions.
Key exclusion criteria (6 listed)
- Individuals receiving full time care in a care facility.
- Individuals that are unable to receive and/or act on interventions.
- Individuals who are existing wearable users, or who have prior experience using a wearable to manage their health.
- Individuals with uncontrolled hypertension, diabetes, CKD or with cardiac pacemakers and/or cardiovascular stent(s).
- Individuals who have any additional condition or situation that the Investigator (PI) or designee determines as inappropriate for participation in this study.
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 |
|---|---|---|
| Fitbit wearing, with notification for sleep, activity and nutrition based fitbit dataNotification on Nutrition, Sleep, and Physical Activity based on fitbit-based data, and Nutritional supplementation and Promotion of Exercise | Device | Intervention |
| Routine careRegular Care on sleep, activity and nutrition | Device | Control |
Primary outcome
Executive function
Time frame: 0 - 6 months
TMT
General Cognition
Time frame: 0 - 6 months
MoCA
Muscle mass
Time frame: 0 - 6 months
Skeletal Muscle mass Index
2 secondary outcomes
Amount of exercise
Time frame: 0 - 6 months
Amount of sleep
Time frame: 0 - 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Derived from this study: PubMed 42831056Sakurai K, Tanaka R, Ledsam J, Shiraishi I, Kasahara H, Anzai S, Watanabe M, Funakawa M, Shimada S, Goto T, Kawabata R, Murasakino K, Kawaura T, Inamura N, Kaneta K, Kobayashi S, Nomura T, Karasawa N, Matsumoto T, Taira T, Ishiguro T, Kudo K, Thompson MJ, Kayama H, Sugawara Y, Warisawa S, Hisatsune T. Effect of a wearable-based individualised multidomain lifestyle intervention on cognitive and physical function in older adults at risk of decline (INSPIOR): a single-centre, open-label, randomised controlled trial. EClinicalMedicine. 2026 Sep 23;100:104212. doi: 10.1016/j.eclinm.2026.104212. eCollection 2026 Oct.
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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.
Tatsuhiro Hisatsune, PhD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit wearing, with notification for sleep, activity and nutrition based fitbit data and Routine care in people with Cognition Disorders in Old Age and Cognitive Function, run by Tokyo University at 1 site in Japan.
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 11 inclusion and 6 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: finished, as of the sponsor's last update on 16 Apr 2026. 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 Japan. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Executive function (time frame: 0 - 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06135740, which also lists 1 linked publication.
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 16 Apr 2026.