- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07513584
Dual-track Residential Exercise With AI and Monitoring for Sleep (DREAMS)
March 30, 2026 updated by: National Sun Yat-sen University
Dual-track Residential Exercise With AI and Monitoring for Sleep in Older Adults With Chronic Insomnia (DREAMS Study)
As societies rapidly transition toward aging demographics, sleep issues among community-dwelling older adults have emerged as a critical concern affecting healthy aging and independent living.
Current single-track exercise intervention models are often difficult to implement due to suboptimal adherence.
Therefore, this study aims to utilize artificial intelligence technology combined with a dual-track residential exercise mode to improve sleep quality, thereby enhancing the self-care and independent living abilities of the elderly
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
The DREAMS Study addresses the critical public health challenge of chronic insomnia among community-dwelling older adults (aged ≥60), which substantially impacts healthy aging and independent living.
Traditional exercise interventions often suffer from suboptimal adherence and rely on subjective self-reporting that fails to capture the physiological "mismatch" between perceived and actual sleep.
To get around these problems, this study uses a home-based, closed-loop, dual-track exercise recommendation model that combines wearable ActiGraph monitoring with AI-driven skeletal recognition technology (iMirror).
This adaptive framework differentiates between insomnia phenotypes: daytime moderate-intensity training (HIIT or resistance exercise) is prescribed to enhance sleep drive for those with difficulty falling asleep (DFA), while nighttime relaxation training (yoga or Pilates) targets reduced hyperarousal for those with difficulty maintaining sleep (DMS).
By utilizing continuous objective data, the system creates a feedback loop that dynamically adjusts exercise prescriptions (frequency, intensity, and timing), reducing the need for on-site professional supervision and ensuring safe implementation within the participant's familiar home environment.
Ultimately, the DREAMS Study establishes a scalable, data-driven model for precision health promotion to inform future policies on sleep health in aging populations.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age ≥ 60 years
- Capable of independent mobility (without the use of assistive devices).4
- Meeting one of the following sleep disturbance criteria:
Core symptoms of DSM-5 chronic insomnia (self-reported) for ≥ 3 months. Insomnia Severity Index (ISI) ≥ 15 (moderate-to-severe insomnia). Pittsburgh Sleep Quality Index (PSQI) > 5 (poor sleep quality).
- Basic ability to use a tablet or smartphone (caregivers may assist with login, but exercise must be performed by the participant).
- Mini-Cog score ≥ 3.
- Consent to wear wearable devices and participate in data collection.
Exclusion Criteria:
- Major cardiovascular events within the past 3 months (e.g., acute myocardial infarction, unstable angina), severe heart failure, or uncontrolled hypertension (e.g., SBP ≥ 180 or DBP ≥ 110 mmHg).
- Severe osteoarticular or neuromuscular diseases that prevent the safe completion of exercise (e.g., recent hip fracture, severe Parkinsonian imbalance).
- Severe psychiatric disorders or substance use disorders that may affect adherence.
- Untreated moderate-to-severe obstructive sleep apnea (OSA) with extreme daytime sleepiness (the study will use objective measurements for preliminary screening).
- Currently receiving structured psychotherapy for insomnia (e.g., CBT-I or BBTi) and not yet stabilized.
- Severe visual or hearing impairment that prevents following voice or visual instructions.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AI-Driven Dual-Track Residential Exercise and Physiological Monitoring Arm
Participants (≥ 60) with chronic insomnia undergo a 12-week home exercise intervention followed by a 12-week follow-up.
The system integrates FitMirror AI skeletal recognition for real-time guidance and ActiGraph wearable monitoring for continuous data collection.
An adaptive closed-loop mechanism tailors exercise to specific insomnia phenotypes: daytime HIIT or resistance training is prescribed to enhance sleep drive for those with sleep-onset difficulties (DFA), while nighttime yoga or Pilates targets reduced hyperarousal for those with maintenance difficulties (DMS).
Effectiveness is evaluated at baseline, 12 weeks, and 24 weeks using linear mixed-effects models to track improvements in multi-dimensional sleep health and functional fitness.
|
The DREAMS Study evaluates an AI-driven, home-based, dual-track exercise intervention for community-dwelling older adults (≥ 60) with chronic insomnia.
Integrating FitMirror skeletal recognition for real-time guidance and ActiGraph wearable monitoring for continuous data collection, the system creates a closed-loop feedback mechanism to optimize sleep health.
The intervention is tailored to insomnia phenotypes: daytime HIIT or resistance training is prescribed to enhance sleep drive (targeting sleep-onset difficulties), while nighttime yoga or Pilates targets reduced hyperarousal (targeting sleep-maintenance difficulties).
Using a quasi-experimental design, the study measures improvements in multi-dimensional sleep health and functional fitness at baseline, post-intervention (12 weeks), and follow-up (24 weeks).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Multi-dimensional Sleep Health Assessment via Objective Actigraphy and Subjective Diaries
Time Frame: Assessments are conducted at three key intervals: Baseline (T0), immediately post-intervention (12 weeks, T1), and at a follow-up (24 weeks, T2).
|
This study evaluates sleep using Buysse's (2018) Multidimensional Sleep Health framework.
To address reviewer concerns regarding distinct units, the following parameters are reported separately: 1) Sleep Efficiency (%) and Duration (min), objectively monitored by ActiGraph wGT3X-BT (7-14 days per stage).
2) Sleep Regularity (min), defined as the standard deviation of the weekly sleep midpoint.
3) Sleep Timing (clock time), representing the average weekly midpoint.
4) Subjective Quality and Daytime Alertness (1-5 scale), captured via daily diaries where lower scores indicate better health.
Actigraphy data are processed at 30-second epochs using ActiLife v6.13.3.
This dual-track approach monitors how daytime HIIT (building sleep drive) and nighttime relaxation (reducing hyperarousal) affect specific insomnia phenotypes, overcoming the "mismatch" between subjective and objective perception.
All metrics are summarized as weekly means
|
Assessments are conducted at three key intervals: Baseline (T0), immediately post-intervention (12 weeks, T1), and at a follow-up (24 weeks, T2).
|
|
Multi-component Functional Physical Fitness Performance
Time Frame: Assessments are conducted at three key intervals: Baseline (T0), immediately post-intervention (12 weeks, T1), and at a follow-up (24 weeks, T2).
|
The specific components of the physical assessment include the 30-second chair stand test to evaluate lower body strength by counting full stands from a seated position, and the 30-second arm curl test to measure upper body strength using 5-pound weights for women or 8-pound weights for men.
Flexibility is assessed through the chair sit-and-reach test for the lower body and the back scratch test for the upper body, with distances measured in centimeters to determine the range of motion in the limbs.
Agility and dynamic balance are recorded using the 8-foot up-and-go test, which times how quickly a participant can rise from a chair, walk 2.44 meters around a marker, and return to a seated position.
Cardiorespiratory endurance is measured using either the 2-minute knee-up test, which counts total repetitions of lifting the knees to a specified height, or the 6-minute walk test, which measures the total distance traveled in meters and can be used to estimate maximal aerobic capacity.
|
Assessments are conducted at three key intervals: Baseline (T0), immediately post-intervention (12 weeks, T1), and at a follow-up (24 weeks, T2).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Composition Analysis via Multi-Frequency Bioelectrical Impedance Analysis
Time Frame: Assessments are conducted at three key intervals: Baseline (T0), immediately post-intervention (12 weeks, T1), and at a follow-up (24 weeks, T2).
|
Measurements are conducted in the morning, 3 hours post-meal, after emptying the bladder and avoiding vigorous exercise to prevent electrolyte and water fluctuations.
Participants stand barefoot on the Tanita MC-780MA Multi-frequency Segmental Body Composition Analyzer, holding hand electrodes with arms positioned away from the torso.
This assessment provides comprehensive data on basal metabolism, visceral fat index, body water, and segmental fat/muscle mass.
Critically, it analyzes the Skeletal Muscle Mass Index (SMI), a key indicator for sarcopenia.
|
Assessments are conducted at three key intervals: Baseline (T0), immediately post-intervention (12 weeks, T1), and at a follow-up (24 weeks, T2).
|
|
Self-Reported Demographic and Clinical Health Profile
Time Frame: Collected at Baseline (T0).
|
Participants self-complete a structured questionnaire covering demographic variables (gender, height, weight, education level) and clinical history, including comorbidities such as hypertension, diabetes, cardiovascular disease, COPD, asthma, cancer, sleep apnea, stroke, or brain injury.
The profile also records the frequency of lifestyle habits (smoking, alcohol, and exercise categorized as none, weekly, monthly, or yearly) and any past diagnosis of psychiatric disorders.
This data ensures proper screening and baseline characterization of the study population.
|
Collected at Baseline (T0).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2026
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2027
Study Registration Dates
First Submitted
March 22, 2026
First Submitted That Met QC Criteria
March 30, 2026
First Posted (Actual)
April 7, 2026
Study Record Updates
Last Update Posted (Actual)
April 7, 2026
Last Update Submitted That Met QC Criteria
March 30, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 11501EC021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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