Sleep QualityNCT07892560
Effects of Different Footbath Immersion Depths on Sleep Quality Among Older Adults in Long-Term Care Facilities
A study testing Ankle-Level Warm-Water Footbath and Below-Knee Warm-Water Footbath in people with Sleep Quality, run by Cai-Syuan Jiang at 6 sites in Taiwan.
Trial summary
Sleep disturbances are common among older adults residing in long-term care facilities. Warm-water footbaths may help improve sleep quality; however, different immersion depths may affect the body's response to warming. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sleep Quality
- What is being tested?
- Ankle-Level Warm-Water Footbath and Below-Knee Warm-Water Footbath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesTaiwan
- Study dates
- 1 Dec 2024to 27 Jan 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65 years or older.
- Resided in a long-term care facility for at least 3 months.
- Intact cognitive function, defined as a Short Portable Mental Status Questionnaire (SPMSQ) score ≥ 7 after adjustment for educational level.
- Experienced sleep disturbances, defined as a Pittsburgh Sleep Quality Index (PSQI) score > 5.
Who cannot join
- Acute illness.
- Psychiatric illness.
- Lower extremity neuropathy.
- Foot wounds.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Taiwan6 sites
Chiayi City Private Boren Elderly Care Center
Chiayi City, Chiayi City, 600
Lantan Jiafu Nursing Home
Chiayi City, Chiayi City, 600
Ruitai Nursing Home (Guangcai Branch)
Chiayi City, Chiayi City, 600
Zhongxiao Nursing Home
Chiayi City, Chiayi City, 600
Madou Sin-Lau Nursing Home, the Presbyterian Church in Taiwan
Madou, Tainan City, 721
Fumao Garden Nursing Home
Shuishang, Chiayi County, 608
About this study
Official title: Effects of Heating Height of Warm Water Footbath on Sleep Quality of Older Adults
Sleep disturbances are common among older adults residing in long-term care facilities. Warm-water footbaths may help improve sleep quality; however, different immersion depths may affect the body's response to warming.
This study examined the effects of warm-water footbaths at different immersion depths on subjective and objective sleep quality among older adults living in long-term care facilities.
Read more
A total of 40 older adults aged 65 years or older from six long-term care facilities in southern Taiwan participated in a crossover study. The study compared three conditions: ankle-level footbaths, below-knee footbaths, and routine care without a footbath.
During the footbath interventions, participants immersed both feet in water at 42°C for 15 minutes approximately one hour before bedtime. Subjective sleep quality was assessed using the Verran and Snyder-Halpern Sleep Scale, and objective sleep quality was measured using wrist actigraphy.
- Conditions
- Sleep Quality
- Being tested
- Ankle-Level Warm-Water Footbath, Below-Knee Warm-Water Footbath
- Keywords
- footbath, Sleep quality, Older adults, Long-term care facilities, passive heating
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle-Level Warm-Water FootbathOther
Participants immersed both feet in warm water at 42°C up to the ankle level for 15 minutes, approximately one hour before bedtime, on two consecutive days.
Below-Knee Warm-Water FootbathOther
Participants immersed both feet and lower legs in warm water at 42°C up to below the knees for 15 minutes, approximately one hour before bedtime, on two consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: Ankle-Level First | Experimental | Twenty participants received ankle-level warm-water footbaths, followed by routine care without footbaths, and then below-knee warm-water footbaths. Each condition lasted two days. Receives: Other: Ankle-Level Warm-Water Footbath; Other: Below-Knee Warm-Water Footbath |
| Sequence 2: Below-Knee First | Experimental | Twenty participants received below-knee warm-water footbaths, followed by routine care without footbaths, and then ankle-level warm-water footbaths. Each condition lasted two days. Receives: Other: Ankle-Level Warm-Water Footbath; Other: Below-Knee Warm-Water Footbath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Sleep Quality Measured by the Verran and Snyder-Halpern Sleep Scale
Subjective sleep quality was assessed using the 15-item Verran and Snyder-Halpern Sleep Scale (VSH). Each item is scored from 0 to 100, with a total score ranging from 0 to 1,500. Higher total scores indicate better subjective sleep quality. The VSH was completed before 9:00 a.m. each morning to assess sleep quality during the previous night. For each study condition, the scores from two consecutive mornings were averaged and compared across the three conditions.
Measured: Over seven consecutive days, from baseline to completion of the interventions, sleep quality was assessed before 9:00 a.m. each morning: once after the baseline night and twice after each two-night condition (ankle-level footbath, routine care, below-kne
Total Sleep Time (TST) Measured by Wrist Actigraphy
Total sleep time (TST) was measured using wrist actigraphy and expressed in minutes. It represents the total time spent asleep during the nighttime sleep period. The device was worn on the nondominant wrist overnight. During footbath conditions, it was fitted after footbath completion; during routine care, it was fitted one hour before bedtime. Devices were collected the following morning before 9:00 a.m. TST values from two consecutive nights under each condition were averaged for analysis.
Measured: Over seven consecutive nights per participant, from baseline to completion of the interventions, total sleep time was assessed nightly: once at baseline and twice for each two-night condition (ankle-level footbath, routine care, below-knee footbath).
Sleep Latency (SL) Measured by Wrist Actigraphy
Sleep latency (SL) was measured using wrist actigraphy and expressed in minutes. It represents the time from bedtime to sleep onset. The device was worn overnight on the nondominant wrist. During footbath conditions, it was fitted after footbath completion; during routine care, it was fitted one hour before bedtime. Devices were collected the following morning before 9:00 a.m. SL values from two consecutive nights under each condition were averaged for analysis.
Measured: Over seven consecutive nights per participant, from baseline to completion of the interventions, sleep latency was assessed nightly: once at baseline and twice for each two-night condition (ankle-level footbath, routine care, below-knee footbath).
Wake After Sleep Onset (WASO) Measured by Wrist Actigraphy
Wake after sleep onset (WASO) was measured using wrist actigraphy and expressed in minutes. It represents the total time spent awake after initially falling asleep during the nighttime sleep period. The device was worn overnight on the nondominant wrist. During footbath conditions, it was fitted after footbath completion; during routine care, it was fitted one hour before bedtime. Devices were collected the following morning before 9:00 a.m. WASO values from two consecutive nights under each condition were averaged for analysis.
Measured: Over seven consecutive nights per participant, from baseline to completion of the interventions, wake after sleep onset was assessed nightly: once at baseline and twice for each two-night condition (ankle-level footbath, routine care, below-knee footbath
Sleep Efficiency (SE) Measured by Wrist Actigraphy
Sleep efficiency (SE) was measured using wrist actigraphy and expressed as a percentage. It was calculated as total sleep time divided by time in bed, multiplied by 100. Higher percentages indicate greater sleep efficiency. The device was worn overnight on the nondominant wrist. During footbath conditions, it was fitted after footbath completion; during routine care, it was fitted one hour before bedtime. Devices were collected the following morning before 9:00 a.m. SE values from two consecutive nights under each condition were averaged for analysis.
Measured: Over seven consecutive nights per participant, from baseline to completion of the interventions, sleep efficiency was assessed nightly: once at baseline and twice for each two-night condition (ankle-level footbath, routine care, below-knee footbath).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start1 Dec 2024
- Primary completion27 Jan 2025
- Study completion27 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants were assigned to one of two intervention sequences, with 20 participants in each sequence. Sequence 1: Ankle-level footbath, routine care, and below-knee footbath. Sequence 2: Below-knee footbath, routine care, and ankle-level footbath. Each condition lasted two days. Sleep outcomes were assessed under each condition.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cai-Syuan Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cai-Syuan Jiang, Chung-Jen Junior College of Nursing, Health Sciences and Management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892560
- Sponsor's protocol ID
- 24C-006
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual participant data (IPD) from this study.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Heating Height of Warm Water Footbath on Sleep Quality of Older Adults
- ClinicalTrials.gov ID
- NCT07892560
- Acronym / sponsor ID
- 24C-006
- Conditions
- Sleep Quality
- Keywords
- footbath, Sleep quality, Older adults, Long-term care facilities, passive heating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cai-Syuan JiangUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 27 Jan 2025 (actual)
- Study completion
- 27 Jan 2025 (actual)
- First posted
- 23 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.
Sleep disturbances are common among older adults residing in long-term care facilities. Warm-water footbaths may help improve sleep quality; however, different immersion depths may affect the body's response to warming.
This study examined the effects of warm-water footbaths at different immersion depths on subjective and objective sleep quality among older adults living in long-term care facilities.
A total of 40 older adults aged 65 years or older from six long-term care facilities in southern Taiwan participated in a crossover study. The study compared three conditions: ankle-level footbaths, below-knee footbaths, and routine care without a footbath.
During the footbath interventions, participants immersed both feet in water at 42°C for 15 minutes approximately one hour before bedtime. Subjective sleep quality was assessed using the Verran and Snyder-Halpern Sleep Scale, and objective sleep quality was measured using wrist actigraphy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were assigned to one of two intervention sequences, with 20 participants in each sequence. Sequence 1: Ankle-level footbath, routine care, and below-knee footbath. Sequence 2: Below-knee footbath, routine care, and ankle-level footbath. Each condition lasted two days. Sleep outcomes were assessed under each condition.
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: Ankle-Level First | Experimental | Other: Ankle-Level Warm-Water Footbath, Other: Below-Knee Warm-Water FootbathTwenty participants received ankle-level warm-water footbaths, followed by routine care without footbaths, and then below-knee warm-water footbaths. Each condition lasted two days. |
| Sequence 2: Below-Knee First | Experimental | Other: Ankle-Level Warm-Water Footbath, Other: Below-Knee Warm-Water FootbathTwenty participants received below-knee warm-water footbaths, followed by routine care without footbaths, and then ankle-level warm-water footbaths. Each condition lasted two days. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Aged 65 years or older.
- Resided in a long-term care facility for at least 3 months.
- Intact cognitive function, defined as a Short Portable Mental Status Questionnaire (SPMSQ) score ≥ 7 after adjustment for educational level.
- Experienced sleep disturbances, defined as a Pittsburgh Sleep Quality Index (PSQI) score > 5.
Key exclusion criteria (4 listed)
- Acute illness.
- Psychiatric illness.
- Lower extremity neuropathy.
- Foot wounds.
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 |
|---|---|---|
| Ankle-Level Warm-Water FootbathParticipants immersed both feet in warm water at 42°C up to the ankle level for 15 minutes, approximately one hour before bedtime, on two consecutive days. | Other | Sequence 1: Ankle-Level First, Sequence 2: Below-Knee First |
| Below-Knee Warm-Water FootbathParticipants immersed both feet and lower legs in warm water at 42°C up to below the knees for 15 minutes, approximately one hour before bedtime, on two consecutive days. | Other | Sequence 1: Ankle-Level First, Sequence 2: Below-Knee First |
Primary outcome
Subjective Sleep Quality Measured by the Verran and Snyder-Halpern Sleep Scale
Time frame: Over seven consecutive days, from baseline to completion of the interventions, sleep quality was assessed before 9:00 a.m. each morning: once after the baseline night and twice after each two-night condition (ankle-level footbath, routine care, below-kne
Subjective sleep quality was assessed using the 15-item Verran and Snyder-Halpern Sleep Scale (VSH). Each item is scored from 0 to 100, with a total score ranging from 0 to 1,500. Higher total scores indicate better subjective sleep quality. The VSH was completed before 9:00 a.m. each morning to assess sleep quality during the previous night. For each study condition, the scores from two consecutive mornings were averaged and compared across the three conditions.
Total Sleep Time (TST) Measured by Wrist Actigraphy
Time frame: Over seven consecutive nights per participant, from baseline to completion of the interventions, total sleep time was assessed nightly: once at baseline and twice for each two-night condition (ankle-level footbath, routine care, below-knee footbath).
Total sleep time (TST) was measured using wrist actigraphy and expressed in minutes. It represents the total time spent asleep during the nighttime sleep period. The device was worn on the nondominant wrist overnight. During footbath conditions, it was fitted after footbath completion; during routine care, it was fitted one hour before bedtime. Devices were collected the following morning before 9:00 a.m. TST values from two consecutive nights under each condition were averaged for analysis.
Sleep Latency (SL) Measured by Wrist Actigraphy
Time frame: Over seven consecutive nights per participant, from baseline to completion of the interventions, sleep latency was assessed nightly: once at baseline and twice for each two-night condition (ankle-level footbath, routine care, below-knee footbath).
Sleep latency (SL) was measured using wrist actigraphy and expressed in minutes. It represents the time from bedtime to sleep onset. The device was worn overnight on the nondominant wrist. During footbath conditions, it was fitted after footbath completion; during routine care, it was fitted one hour before bedtime. Devices were collected the following morning before 9:00 a.m. SL values from two consecutive nights under each condition were averaged for analysis.
Wake After Sleep Onset (WASO) Measured by Wrist Actigraphy
Time frame: Over seven consecutive nights per participant, from baseline to completion of the interventions, wake after sleep onset was assessed nightly: once at baseline and twice for each two-night condition (ankle-level footbath, routine care, below-knee footbath
Wake after sleep onset (WASO) was measured using wrist actigraphy and expressed in minutes. It represents the total time spent awake after initially falling asleep during the nighttime sleep period. The device was worn overnight on the nondominant wrist. During footbath conditions, it was fitted after footbath completion; during routine care, it was fitted one hour before bedtime. Devices were collected the following morning before 9:00 a.m. WASO values from two consecutive nights under each condition were averaged for analysis.
Sleep Efficiency (SE) Measured by Wrist Actigraphy
Time frame: Over seven consecutive nights per participant, from baseline to completion of the interventions, sleep efficiency was assessed nightly: once at baseline and twice for each two-night condition (ankle-level footbath, routine care, below-knee footbath).
Sleep efficiency (SE) was measured using wrist actigraphy and expressed as a percentage. It was calculated as total sleep time divided by time in bed, multiplied by 100. Higher percentages indicate greater sleep efficiency. The device was worn overnight on the nondominant wrist. During footbath conditions, it was fitted after footbath completion; during routine care, it was fitted one hour before bedtime. Devices were collected the following morning before 9:00 a.m. SE values from two consecutive nights under each condition were averaged for analysis.
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 23 Oct 2026.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data (IPD) from this study.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle-Level Warm-Water Footbath and Below-Knee Warm-Water Footbath in people with Sleep Quality, run by Cai-Syuan Jiang at 6 sites 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 4 inclusion and 4 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 23 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 6 sites 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?
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?
Subjective Sleep Quality Measured by the Verran and Snyder-Halpern Sleep Scale (time frame: Over seven consecutive days, from baseline to completion of the interventions, sleep quality was assessed before 9:00 a.m. each morning: once after the baseline night and twice after each two-night condition (ankle-level footbath, routine care, below-kne). The study lists 5 primary outcomes in all. 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 23 Oct 2026.