Insomnia ChronicNCT07896603
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
A study testing resistance training and Relaxation training in people with Insomnia Chronic and Hypnotics and Sedatives, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Background: The prevalence of sedative-hypnotic use among middle-aged and older adults in Taiwan has continued to rise, highlighting the need to better understand the underlying factors contributing to sleep disturbances and medication dependence. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Insomnia Chronic, Hypnotics and Sedatives, Physical Activities
- What is being tested?
- resistance training and Relaxation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years old
- Sedative-hypnotic use for more than 6 months
Who cannot join
- Inability to perform informed consent.
- Unstable or severe medical conditions that may interfere with participation, such as uncontrolled cardiovascular disease, advanced chronic obstructive pulmonary disease, recent stroke (<6 months), or severe renal/hepatic failure.
- Neuromuscular or orthopedic disorders that limit safe participation in resistance training (e.g., severe arthritis, recent fractures, progressive neuromuscular diseases).
- Current diagnosis of major psychiatric disorders (e.g., uncontrolled major depressive disorder, bipolar disorder, psychosis) that may impair adherence.
- Current participation in a structured exercise program ≥2 days/week in the last 3 months, which may confound intervention effects.
- Currently under psychotherapy or ever received non-pharmacological treatment for insomnia
- Any condition judged by the investigator to pose a safety risk or interfere with study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Background:
The prevalence of sedative-hypnotic use among middle-aged and older adults in Taiwan has continued to rise, highlighting the need to better understand the underlying factors contributing to sleep disturbances and medication dependence. Emerging evidence suggests that, beyond psychological and behavioral contributors, age-related physiological decline may play an important role. Sarcopenia, characterized by progressive loss of muscle mass and strength, is common in aging populations and has been linked to poor sleep quality, daytime fatigue, increased fall risk, and higher medication use. Regular physical activity not only improves symptoms of sarcopenia but has also been shown to enhance subjective sleep quality and modify objective sleep architecture, including increases in N3 slow-wave sleep. Despite these benefits, no study to date has directly examined whether physical activity can facilitate sedative-hypnotic dose reduction among chronic users.
Read more
Purpose:
The aim of this study is to investigate the associations among sarcopenia, sleep disturbances, and sedative-hypnotic use, and to evaluate the effectiveness of a structured physical activity intervention in improving subjective and objective sleep outcomes and promoting dose reduction in chronic hypnotic users.
Methods:
This three-year study will recruit 180 adults aged 50 years and older who have long-term sedative-hypnotic use. Participants will be randomly assigned to either an individualized 12-week physical activity program or a relaxation training control condition. Baseline and post-intervention assessments will include subjective sleep questionnaires, polysomnography, muscle strength and mass measurements, and standardized hypnotic dose quantification.
Expected Results:
Investigators anticipate that physical activity targeting muscle health will significantly improve sleep quality and contribute to meaningful reductions in sedative-hypnotic medication use among chronic users.
- Being tested
- resistance training, Relaxation training
- Keywords
- Physical activity, Exercise, Sarcopenia, Insomnia, Sedative-hypnotic, Middle age, Elders
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Motor Activity, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resistance trainingBehavioural
The program will rely mainly on body weight movements supplemented with elastic resistance bands and will be performed at an intensity corresponding to eight to twelve repetition maximum.
Relaxation trainingBehavioural
This training will include instruction in abdominal breathing and progressive muscle relaxation. An audio recording of the relaxation script will be provided, and participants will be asked to practice at home one to two times each week for a total duration of three months.
| Study group | Role | What they receive |
|---|---|---|
| resistance training for 12 weeks | Experimental | Not described Receives: Behavioral: resistance training |
| relaxation training for 12 weeks | Active comparator | Not described Receives: Behavioral: Relaxation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Dose equivalent for statistical purpose (S-DDD)
Sedative-hypnotic medications constitute a heterogeneous group that includes benzodiazepines, non-benzodiazepine Z-drugs, and other agents with sleep-promoting properties. Because these medications vary substantially in potency, half-life, receptor specificity, and clinically prescribed daily doses, direct comparison of milligram quantities is not meaningful. To permit standardized analysis, the prescribed dose of each hypnotic medication will be converted into its corresponding WHO Defined Daily Dose equivalent for statistical purpose (S-DDD). The dosage of sedative-hypnotic medications was standardized by dividing each participant's prescribed dose by the World Health Organization assigned Defined Daily Dose (DDD) for the corresponding medication (WHO Collaborating Centre for Drug Statistics Methodology, 2024), expressed in DDDs. Changes in medication use from baseline to the three-month post-intervention assessment were compared both within and between the two groups.
Measured: baseline and three-month post-intervention assessment
Secondary outcomes (4)
Global Physical Activity Questionnaire (GPAQ)
Physical activity levels were assessed using the Global Physical Activity Questionnaire (GPAQ) following WHO scoring guidelines (Keating et al., 2019). Weekly minutes of vigorous, moderate, and transport-related activity were multiplied by assigned MET values (8.0 for vigorous, 4.0 for moderate and transport) to calculate MET-minutes per week. Total physical activity was obtained by summing MET-minutes across all domains. Higher MET values indicate higher levels of physical activity among participants. Differences in MET values at baseline and after the 3-month intervention were compared both within participants and between the two groups.
Measured: baseline and three months after the end of interventions
The Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a predominant, self-reported measurement tool for evaluating subjective sleep quality. This instrument is structured around nineteen individual items which are aggregated into seven distinct component scores. These components comprehensively cover key dimensions of sleep, specifically: sleep duration, sleep latency, habitual sleep efficiency, frequency of sleep disturbances, reliance on sleep medication, presence of daytime dysfunction, and the individual's global perception of their sleep quality. Each of the seven components is rated on a 0 to 3 scale, which generates a final Global PSQI Score ranging from 0 to 21 with higher values indicating poorer sleep quality. A global score greater than five is commonly used as the clinical cutoff for identifying individuals with meaningful sleep disturbance. The PSQI has demonstrated strong reliability, validity, and sensitivity to change across a wide range of populations (Buysse et al., 1989)
Measured: baseline and three months after the end of interventions
Polysomnography (PSG)
Polysomnography (PSG) records multiple physiological signals simultaneously during an overnight sleep study, including electroencephalography (EEG), electrooculography (EOG), and electromyography (EMG), to evaluate brain activity, eye movements, and muscle tone. These measurements enable accurate identification of sleep stages, including non-rapid eye movement (NREM) stages N1, N2, and N3, as well as rapid eye movement (REM) sleep, allowing detailed assessment of sleep architecture. It also incorporates additional monitoring, such as airflow and oxygen saturation, to detect sleep-related breathing disorders and other physiological abnormalities. Furthermore, it provides quantitative measures of sleep continuity, including total sleep time, sleep efficiency, and sleep onset latency, together with physiological events such as arousals and respiratory events. PSG allow researchers to comprehensively evaluate participants' sleep characteristics.
Measured: baseline and three months after the end of interventions
Sarcopenia evaluation
According to the latest 2025 guidelines released by the Asian Working Group for Sarcopenia (AWGS), the assessment of sarcopenia includes handgrip strength (kg), calf circumference (cm), gait speed (m/s), five-times chair stand test (s), and dual-energy X-ray absorptiometry (DXA). DXA was used to assess skeletal muscle mass. The skeletal muscle mass was adjusted by dividing the muscle mass value by the participant's BMI to enable comparisons among participants, with the unit expressed as kg/m². In this study, changes in sarcopenia-related parameters, including handgrip strength, calf circumference, gait speed, five-times chair stand time, and muscle mass adjusted for BMI, were compared within participants between baseline and after the 3-month intervention. Differences in these parameters were also examined between groups.
Measured: baseline and three months after the end of interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Jul 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia ChronicStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention method: * Treatment group: resistance training for 12 weeks * control group: relaxation training for 12 weeks
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896603
- Sponsor's protocol ID
- 202501691A3C5001
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
- ClinicalTrials.gov ID
- NCT07896603
- Acronym / sponsor ID
- 202501691A3C5001
- Keywords
- Physical activity, Exercise, Sarcopenia, Insomnia, Sedative-hypnotic, Middle age, Elders
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 27 Oct 2026 (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.
Background:
The prevalence of sedative-hypnotic use among middle-aged and older adults in Taiwan has continued to rise, highlighting the need to better understand the underlying factors contributing to sleep disturbances and medication dependence. Emerging evidence suggests that, beyond psychological and behavioral contributors, age-related physiological decline may play an important role. Sarcopenia, characterized by progressive loss of muscle mass and strength, is common in aging populations and has been linked to poor sleep quality, daytime fatigue, increased fall risk, and higher medication use. Regular physical activity not only improves symptoms of sarcopenia but has also been shown to enhance subjective sleep quality and modify objective sleep architecture, including increases in N3 slow-wave sleep. Despite these benefits, no study to date has directly examined whether physical activity can facilitate sedative-hypnotic dose reduction among chronic users.
Purpose:
The aim of this study is to investigate the associations among sarcopenia, sleep disturbances, and sedative-hypnotic use, and to evaluate the effectiveness of a structured physical activity intervention in improving subjective and objective sleep outcomes and promoting dose reduction in chronic hypnotic users.
Methods:
This three-year study will recruit 180 adults aged 50 years and older who have long-term sedative-hypnotic use. Participants will be randomly assigned to either an individualized 12-week physical activity program or a relaxation training control condition. Baseline and post-intervention assessments will include subjective sleep questionnaires, polysomnography, muscle strength and mass measurements, and standardized hypnotic dose quantification.
Expected Results:
Investigators anticipate that physical activity targeting muscle health will significantly improve sleep quality and contribute to meaningful reductions in sedative-hypnotic medication use among chronic users.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention method: * Treatment group: resistance training for 12 weeks * control group: relaxation training for 12 weeks
| Arm | Type | Receives |
|---|---|---|
| resistance training for 12 weeks | Experimental | Behavioral: resistance training |
| relaxation training for 12 weeks | Active comparator | Behavioral: Relaxation training |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 50 years old
- Sedative-hypnotic use for more than 6 months
Key exclusion criteria (7 listed)
- Inability to perform informed consent.
- Unstable or severe medical conditions that may interfere with participation, such as uncontrolled cardiovascular disease, advanced chronic obstructive pulmonary disease, recent stroke (<6 months), or severe renal/hepatic failure.
- Neuromuscular or orthopedic disorders that limit safe participation in resistance training (e.g., severe arthritis, recent fractures, progressive neuromuscular diseases).
- Current diagnosis of major psychiatric disorders (e.g., uncontrolled major depressive disorder, bipolar disorder, psychosis) that may impair adherence.
- Current participation in a structured exercise program ≥2 days/week in the last 3 months, which may confound intervention effects.
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 |
|---|---|---|
| resistance trainingThe program will rely mainly on body weight movements supplemented with elastic resistance bands and will be performed at an intensity corresponding to eight to twelve repetition maximum. | Behavioural | resistance training for 12 weeks |
| Relaxation trainingThis training will include instruction in abdominal breathing and progressive muscle relaxation. An audio recording of the relaxation script will be provided, and participants will be asked to practice at home one to two times each week for a total duration of three months. | Behavioural | relaxation training for 12 weeks |
Primary outcome
Daily Dose equivalent for statistical purpose (S-DDD)
Time frame: baseline and three-month post-intervention assessment
Sedative-hypnotic medications constitute a heterogeneous group that includes benzodiazepines, non-benzodiazepine Z-drugs, and other agents with sleep-promoting properties. Because these medications vary substantially in potency, half-life, receptor specificity, and clinically prescribed daily doses, direct comparison of milligram quantities is not meaningful. To permit standardized analysis, the prescribed dose of each hypnotic medication will be converted into its corresponding WHO Defined Daily Dose equivalent for statistical purpose (S-DDD). The dosage of sedative-hypnotic medications was standardized by dividing each participant's prescribed dose by the World Health Organization assigned Defined Daily Dose (DDD) for the corresponding medication (WHO Collaborating Centre for Drug Statistics Methodology, 2024), expressed in DDDs. Changes in medication use from baseline to the three-month post-intervention assessment were compared both within and between the two groups.
4 secondary outcomes
Global Physical Activity Questionnaire (GPAQ)
Time frame: baseline and three months after the end of interventions
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: baseline and three months after the end of interventions
Polysomnography (PSG)
Time frame: baseline and three months after the end of interventions
Sarcopenia evaluation
Time frame: baseline and three months after the end of interventions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resistance training and Relaxation training in people with Insomnia Chronic and Hypnotics and Sedatives, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 27 Oct 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 Taiwan. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Daily Dose equivalent for statistical purpose (S-DDD) (time frame: baseline and three-month post-intervention assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2026.