Sleep FragmentationNCT07841938
Acupuncture for Sleep Fragmentation in Older Adults: A Single-Arm Pilot Study
A study testing Acupuncture in people with Sleep Fragmentation and Poor Sleep Quality, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
Trial summary
This single-group pilot study will enroll 20 adults aged 60 years or older with persistent poor sleep. All participants will receive a standardized 6-week acupuncture program. The study will assess feasibility and preliminary changes in actigraphy-derived sleep fragmentation, self-reported sleep, brain DTI-ALPS… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sleep Fragmentation, Poor Sleep Quality
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Oct 2026to 31 Oct 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60 years or older.
- Subjective poor sleep for at least 3 months.
- Pittsburgh Sleep Quality Index (PSQI) total score greater than 5.
- Willing and able to complete study assessments and the 6-week intervention.
- Mini-Mental State Examination (MMSE) score of 24 or higher.
- Provides written informed consent.
Who cannot join
- Diagnosed dementia, Parkinson disease, or another progressive neurodegenerative disorder.
- Stroke or severe head injury within the prior year.
- Unstable major psychiatric illness.
- AD8 score of 2 or higher or Geriatric Depression Scale (GDS) score of 5 or higher.
- Severe sensory or comprehension problems that prevent study participation.
- Night-shift work or frequent recent transmeridian travel.
Show all 15Show fewer
- Current CPAP or BiPAP use, or severe obstructive sleep apnea requiring immediate treatment, such as an apnea-hypopnea index greater than 30 with oxygen desaturation.
- Use of 3 or more hypnotic medications with inability to maintain a stable dose.
- Contraindication to magnetic resonance imaging.
- Major neck surgery, neck radiation, or vascular anomaly that interferes with jugular ultrasonography.
- Severe unstable systemic disease.
- Severe coagulopathy or anticoagulation that makes acupuncture unsuitable.
- Infection or wound at an acupuncture site.
- Severe gait instability or inability to attend scheduled visits.
- Any other condition that the investigator considers unsuitable for participation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites
Linkou Chang Gung Memorial Hospital
Taoyuan, Taoyuan, 333
Geng-Hao Liu, +886-975362734, ghliu.wis@gmail.com
Taoyuan Chang Gung Memorial Hospital
Taoyuan, Taoyuan, 333
Geng-Hao Liu, +886-975362734, ghliu.wis@gmail.com
About this study
Official title: Translational Research on Acupuncture Modulation of Sleep Fragmentation and Glymphatic Function in Aging: A Single-Arm Pilot Study
This single-group pilot study will enroll 20 adults aged 60 years or older with persistent poor sleep. All participants will receive a standardized 6-week acupuncture program. The study will assess feasibility and preliminary changes in actigraphy-derived sleep fragmentation, self-reported sleep, brain DTI-ALPS imaging, internal jugular venous ultrasonography, and CERAD-NB word-list memory performance.
Read the detailed description
After written informed consent, participants will complete cognitive and mood screening. Baseline assessments include PSQI, ISI, ESS, CERAD-NB word-list memory testing, one night of home polysomnography, 7 days of actigraphy, brain MRI for the DTI-ALPS index, and internal jugular venous ultrasonography. Participants will then receive acupuncture twice weekly for 6 weeks, for 12 sessions, with each session lasting approximately 20 to 30 minutes. ISI will also be assessed at Weeks 2 and 4. At Week 6, baseline assessments will be repeated except for home polysomnography. PSQI, ISI, and ESS will be collected again approximately 3 months after treatment as an optional follow-up. Missing data from this optional follow-up alone will not exclude a participant from the per-protocol population. Exploratory analyses will examine whether actigraphy-derived physical activity and light exposure are associated with, or modify, changes in the registered sleep, imaging, and cognitive outcomes.
- Conditions
- Sleep Fragmentation, Poor Sleep Quality
- Being tested
- Acupuncture
- Keywords
- Older Adults, Acupuncture, Glymphatic System, DTI-ALPS, Actigraphy, Cognitive Function
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Participants will receive acupuncture at Baihui (GV20), Anmian (EX-HN22), Zusanli (ST36), and Taixi (KI3) twice weekly for 6 weeks, for a total of 12 sessions. Needles will be retained for approximately 20 to 30 minutes per session. No comparator arm is used in this pilot.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Participants receive a 6-week standardized acupuncture program. Receives: Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 7-day mean wake after sleep onset from baseline to Week 6
Change equals the Week 6 mean minus the baseline mean. Wake after sleep onset (WASO) is the total minutes scored awake between sleep onset and final awakening for each valid night. Sleep is measured with Actiwatch 2 (Philips Respironics) worn on the nondominant wrist, recorded in 60-second epochs, and scored with Philips Actiware version 6.0.9 using sleep diaries. Each timepoint is the mean across all valid nights in the 7-day assessment window. A timepoint is valid if it includes at least 5 valid nights, including at least 1 weekend night; otherwise it is treated as missing. Unit: minutes.
Measured: Baseline and Week 6
Secondary outcomes (9)
Change in 7-day mean sleep efficiency from baseline to Week 6
Change equals the Week 6 mean minus the baseline mean. Sleep efficiency is the percentage of time in bed scored as sleep for each valid night. Sleep is measured with Actiwatch 2 (Philips Respironics) worn on the nondominant wrist, recorded in 60-second epochs, and scored with Philips Actiware version 6.0.9 using sleep diaries. Each timepoint is the mean across all valid nights in the 7-day assessment window. A timepoint is valid if it includes at least 5 valid nights, including at least 1 weekend night; otherwise it is treated as missing. Unit: percentage points.
Measured: Baseline and Week 6
Change in Pittsburgh Sleep Quality Index total score over time
The Pittsburgh Sleep Quality Index total score ranges from 0 to 21; higher scores indicate poorer sleep quality. Change at Week 6 and at the optional approximately 3-month post-treatment follow-up equals the respective follow-up score minus baseline.
Measured: Baseline, Week 6, and approximately 3 months after treatment
Change in 7-day mean number of awakenings from baseline to Week 6
Change equals the Week 6 mean minus the baseline mean. Actiware-derived awakenings are counted for each valid night. Sleep is measured with Actiwatch 2 (Philips Respironics) worn on the nondominant wrist, recorded in 60-second epochs, and scored with Philips Actiware version 6.0.9 using sleep diaries. Each timepoint is the mean across all valid nights in the 7-day assessment window. A timepoint is valid if it includes at least 5 valid nights, including at least 1 weekend night; otherwise it is treated as missing. Unit: awakenings per night.
Measured: Baseline and Week 6
Change in 7-day mean sleep fragmentation index from baseline to Week 6
Change equals the Week 6 mean minus the baseline mean. For each valid night, the Actiware 6.0.9 sleep fragmentation index is the sum of (1) the percentage of epochs classified as mobile during the sleep interval and (2) the percentage of all immobile bouts lasting no more than 1 minute. Higher values indicate greater sleep fragmentation. Actiwatch 2 is worn on the nondominant wrist and recorded in 60-second epochs. Each timepoint is the mean across valid nights in the 7-day window. A timepoint requires at least 5 valid nights, including at least 1 weekend night; otherwise it is missing. Unit: percentage points.
Measured: Baseline and Week 6
Change in Insomnia Severity Index total score over time
The Insomnia Severity Index total score ranges from 0 to 28; higher scores indicate greater insomnia severity. Change at Weeks 2, 4, and 6 and at the optional approximately 3-month post-treatment follow-up equals the respective follow-up score minus baseline.
Measured: Baseline, Weeks 2, 4, and 6, and approximately 3 months after treatment
Change in Epworth Sleepiness Scale total score over time
The Epworth Sleepiness Scale total score ranges from 0 to 24; higher scores indicate greater daytime sleepiness. Change at Week 6 and at the optional approximately 3-month post-treatment follow-up equals the respective follow-up score minus baseline.
Measured: Baseline, Week 6, and approximately 3 months after treatment
Change in diffusion tensor imaging along the perivascular space index from baseline to Week 6
Change equals the Week 6 value minus the baseline value for the diffusion tensor imaging along the perivascular space (DTI-ALPS) index. Unit: unitless (dimensionless index).
Measured: Baseline and Week 6
Change in side-specific internal jugular vein time-averaged mean blood-flow velocity from baseline to Week 6
Change equals the Week 6 value minus baseline for time-averaged mean velocity measured by pulsed-wave Doppler ultrasonography with the participant supine and the head in a neutral position. The left and right internal jugular veins are measured and analyzed separately; values are not combined by a simple bilateral average. Repeated measurements for each side are averaged. Unit: centimeters per second (cm/s).
Measured: Baseline and Week 6
Change in side-specific internal jugular vein cross-sectional area from baseline to Week 6
Change equals the Week 6 value minus baseline for cross-sectional area measured by transverse B-mode ultrasonography with the participant supine and the head in a neutral position. The left and right internal jugular veins are measured and analyzed separately; values are not combined by a simple bilateral average. Repeated measurements for each side are averaged. Minimal transducer pressure is used to avoid vein compression. Unit: square centimeters (cm²).
Measured: Baseline and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep FragmentationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- Principal investigator, Geng-Hao Liu, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841938
- Sponsor's protocol ID
- 202502000A3-PILOT
- Other IDs
- NSTC 115-2320-B-182-022-MY3
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2026
- Last updated
- 25 Sep 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 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational Research on Acupuncture Modulation of Sleep Fragmentation and Glymphatic Function in Aging: A Single-Arm Pilot Study
- ClinicalTrials.gov ID
- NCT07841938
- Acronym / sponsor ID
- 202502000A3-PILOT
- Conditions
- Sleep Fragmentation, Poor Sleep Quality
- Keywords
- Older Adults, Acupuncture, Glymphatic System, DTI-ALPS, Actigraphy, Cognitive Function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 25 Sep 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.
This single-group pilot study will enroll 20 adults aged 60 years or older with persistent poor sleep. All participants will receive a standardized 6-week acupuncture program. The study will assess feasibility and preliminary changes in actigraphy-derived sleep fragmentation, self-reported sleep, brain DTI-ALPS imaging, internal jugular venous ultrasonography, and CERAD-NB word-list memory performance.
Detailed description
After written informed consent, participants will complete cognitive and mood screening. Baseline assessments include PSQI, ISI, ESS, CERAD-NB word-list memory testing, one night of home polysomnography, 7 days of actigraphy, brain MRI for the DTI-ALPS index, and internal jugular venous ultrasonography. Participants will then receive acupuncture twice weekly for 6 weeks, for 12 sessions, with each session lasting approximately 20 to 30 minutes. ISI will also be assessed at Weeks 2 and 4. At Week 6, baseline assessments will be repeated except for home polysomnography. PSQI, ISI, and ESS will be collected again approximately 3 months after treatment as an optional follow-up. Missing data from this optional follow-up alone will not exclude a participant from the per-protocol population. Exploratory analyses will examine whether actigraphy-derived physical activity and light exposure are associated with, or modify, changes in the registered sleep, imaging, and cognitive outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Procedure: AcupunctureParticipants receive a 6-week standardized acupuncture program. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 60 years or older.
- Subjective poor sleep for at least 3 months.
- Pittsburgh Sleep Quality Index (PSQI) total score greater than 5.
- Willing and able to complete study assessments and the 6-week intervention.
- Mini-Mental State Examination (MMSE) score of 24 or higher.
Key exclusion criteria (15 listed)
- Diagnosed dementia, Parkinson disease, or another progressive neurodegenerative disorder.
- Stroke or severe head injury within the prior year.
- Unstable major psychiatric illness.
- AD8 score of 2 or higher or Geriatric Depression Scale (GDS) score of 5 or higher.
- Severe sensory or comprehension problems that prevent study participation.
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 |
|---|---|---|
| AcupunctureParticipants will receive acupuncture at Baihui (GV20), Anmian (EX-HN22), Zusanli (ST36), and Taixi (KI3) twice weekly for 6 weeks, for a total of 12 sessions. Needles will be retained for approximately 20 to 30 minutes per session. No comparator arm is used in this pilot. | Procedure or surgery | Acupuncture |
Primary outcome
Change in 7-day mean wake after sleep onset from baseline to Week 6
Time frame: Baseline and Week 6
Change equals the Week 6 mean minus the baseline mean. Wake after sleep onset (WASO) is the total minutes scored awake between sleep onset and final awakening for each valid night. Sleep is measured with Actiwatch 2 (Philips Respironics) worn on the nondominant wrist, recorded in 60-second epochs, and scored with Philips Actiware version 6.0.9 using sleep diaries. Each timepoint is the mean across all valid nights in the 7-day assessment window. A timepoint is valid if it includes at least 5 valid nights, including at least 1 weekend night; otherwise it is treated as missing. Unit: minutes.
9 secondary outcomes
Change in 7-day mean sleep efficiency from baseline to Week 6
Time frame: Baseline and Week 6
Change in Pittsburgh Sleep Quality Index total score over time
Time frame: Baseline, Week 6, and approximately 3 months after treatment
Change in 7-day mean number of awakenings from baseline to Week 6
Time frame: Baseline and Week 6
Change in 7-day mean sleep fragmentation index from baseline to Week 6
Time frame: Baseline and Week 6
Change in Insomnia Severity Index total score over time
Time frame: Baseline, Weeks 2, 4, and 6, and approximately 3 months after treatment
Change in Epworth Sleepiness Scale total score over time
Time frame: Baseline, Week 6, and approximately 3 months after treatment
Change in diffusion tensor imaging along the perivascular space index from baseline to Week 6
Time frame: Baseline and Week 6
Change in side-specific internal jugular vein time-averaged mean blood-flow velocity from baseline to Week 6
Time frame: Baseline and Week 6
Change in side-specific internal jugular vein cross-sectional area from baseline to Week 6
Time frame: Baseline and Week 6
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 25 Sep 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Sleep Fragmentation and Poor Sleep Quality, run by Chang Gung Memorial Hospital at 2 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 6 inclusion and 15 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: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 7-day mean wake after sleep onset from baseline to Week 6 (time frame: Baseline and Week 6). 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 25 Sep 2026.