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Acupuncture for Sleep Fragmentation in Older Adults: A Single-Arm Pilot Study

20. september 2026 oppdatert av: Geng-Hao Liu, Chang Gung Memorial Hospital

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Taiwan
    • Taoyuan
      • Taoyuan, Taoyuan, Taiwan, 333
        • Linkou Chang Gung Memorial Hospital
        • Ta kontakt med:
      • Taoyuan, Taoyuan, Taiwan, 333
        • Taoyuan Chang Gung Memorial Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

60 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Age 60 years or older.
  2. Subjective poor sleep for at least 3 months.
  3. Pittsburgh Sleep Quality Index (PSQI) total score greater than 5.
  4. Willing and able to complete study assessments and the 6-week intervention.
  5. Mini-Mental State Examination (MMSE) score of 24 or higher.
  6. Provides written informed consent.

Exclusion Criteria:

  1. Diagnosed dementia, Parkinson disease, or another progressive neurodegenerative disorder.
  2. Stroke or severe head injury within the prior year.
  3. Unstable major psychiatric illness.
  4. AD8 score of 2 or higher or Geriatric Depression Scale (GDS) score of 5 or higher.
  5. Severe sensory or comprehension problems that prevent study participation.
  6. Night-shift work or frequent recent transmeridian travel.
  7. 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.
  8. Use of 3 or more hypnotic medications with inability to maintain a stable dose.
  9. Contraindication to magnetic resonance imaging.
  10. Major neck surgery, neck radiation, or vascular anomaly that interferes with jugular ultrasonography.
  11. Severe unstable systemic disease.
  12. Severe coagulopathy or anticoagulation that makes acupuncture unsuitable.
  13. Infection or wound at an acupuncture site.
  14. Severe gait instability or inability to attend scheduled visits.
  15. Any other condition that the investigator considers unsuitable for participation.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Acupuncture

Participants receive a 6-week standardized acupuncture program.
Fremgangsmåte: Acupuncture

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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in 7-day mean wake after sleep onset from baseline to Week 6
Tidsramme: 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.
Baseline and Week 6

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in 7-day mean sleep efficiency from baseline to Week 6
Tidsramme: Baseline and 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.
Baseline and Week 6
Change in Pittsburgh Sleep Quality Index total score over time
Tidsramme: Baseline, Week 6, and approximately 3 months after treatment

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.
Baseline, Week 6, and approximately 3 months after treatment
Change in 7-day mean number of awakenings from baseline to Week 6
Tidsramme: Baseline and 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.
Baseline and Week 6
Change in 7-day mean sleep fragmentation index from baseline to Week 6
Tidsramme: Baseline and 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.
Baseline and Week 6
Change in Insomnia Severity Index total score over time
Tidsramme: Baseline, Weeks 2, 4, and 6, and approximately 3 months after treatment

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.
Baseline, Weeks 2, 4, and 6, and approximately 3 months after treatment
Change in Epworth Sleepiness Scale total score over time
Tidsramme: Baseline, Week 6, and approximately 3 months after treatment

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.
Baseline, Week 6, and approximately 3 months after treatment
Change in diffusion tensor imaging along the perivascular space index from baseline to Week 6
Tidsramme: Baseline and 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).
Baseline and Week 6
Change in side-specific internal jugular vein time-averaged mean blood-flow velocity from baseline to Week 6
Tidsramme: Baseline and 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).
Baseline and Week 6
Change in side-specific internal jugular vein cross-sectional area from baseline to Week 6
Tidsramme: Baseline and 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).
Baseline and Week 6

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in CERAD-NB word-list memory composite score from baseline to Week 6
Tidsramme: Baseline and Week 6

Change equals the Week 6 score minus baseline. The composite is the sum of word-list learning across 3 trials (0-30), delayed recall (0-10), and recognition discriminability (0-10), for a total range of 0-50; higher scores indicate better memory performance. Recognition discriminability is calculated as correct "Yes" responses plus correct "No" responses minus 10; values below 0 are scored as 0. Remote memory is not included in this composite.
Baseline and Week 6
Proportion of participants completing at least 10 of 12 acupuncture sessions
Tidsramme: Through Week 6

Number of enrolled participants who complete at least 10 of the 12 planned acupuncture sessions divided by the total number enrolled, multiplied by 100. This threshold corresponds to at least 80% treatment adherence. Unit: percentage of participants.
Through Week 6
Proportion of participants completing the Week 6 primary outcome assessment
Tidsramme: Week 6

Number of enrolled participants who complete the Week 6 assessment of the primary outcome, 7-day mean wake after sleep onset, divided by the total number enrolled, multiplied by 100. Unit: percentage of participants.
Week 6
Proportion of participants with valid actigraphy data at both baseline and Week 6
Tidsramme: Baseline and Week 6

Number of enrolled participants with valid actigraphy timepoints at both baseline and Week 6 divided by the total number enrolled, multiplied by 100. Each timepoint requires at least 5 valid nights, including at least 1 weekend night. Unit: percentage of participants.
Baseline and Week 6

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Chang Gung Memorial Hospital

Samarbeidspartnere

National Science and Technology Council, Taiwan

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

31. juli 2027

Studiet fullført (Antatt)

31. oktober 2027

Datoer for studieregistrering

Først innsendt

20. september 2026

Først innsendt som oppfylte QC-kriteriene

20. september 2026

Først lagt ut (Faktiske)

25. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 202502000A3-PILOT
  • NSTC 115-2320-B-182-022-MY3 (Annet stipend/finansieringsnummer: National Science and Technology Council, Taiwan)

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