Binaural Beats for Cognitive Function in Older Adults With Mild Cognitive Impairment in Nursing Homes (BB-MCI)
27. juli 2026 oppdatert av: Yuhan Geng, China Medical University, China
The Effect of Binaural Beats on Cognitive Function in Older Adults With Mild Cognitive Impairment in Nursing Homes: A Randomized Controlled Trial
This study will evaluate whether binaural beats can improve cognitive function in older adults with mild cognitive impairment living in nursing homes.
Participants will listen to 10-Hz alpha-frequency binaural beats through headphones once daily for 30 minutes for 14 consecutive days.
Cognitive function, sleep quality, anxiety, and depressive symptoms will be assessed before the intervention, after the intervention, and at a 2-week follow-up after the intervention.
The study aims to determine whether binaural beats are a safe, simple, and non-drug approach to support cognitive health in older adults with mild cognitive impairment.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Liu Yu Yu Liu, Professor
- Telefonnummer: +8618640068209
- E-post: liuyu@cmu.edu.cn
Studiesteder
-
-
Liaoning
-
Shenyang, Liaoning, Kina, 110030
- Rekruttering
- Jintaiyang Jingguan Elderly Care Apartment
-
Ta kontakt med:
- Yuhan Geng
- Telefonnummer: 18018945883
- E-post: gengyuhan@cmu.edu.cn
-
Shenyang, Liaoning, Kina, 110031
- Rekruttering
- Jintaiyang Elderly Care Center, Huanggu Branch
-
Ta kontakt med:
- Yuhan Geng
- Telefonnummer: 18018945883
- E-post: gengyuhan@cmu.edu.cn
-
Shenyang, Liaoning, Kina, 110042
- Rekruttering
- Renai Changwan Elderly Care Home, Dadong District
-
Ta kontakt med:
- Yuhan Geng
- Telefonnummer: 18018945883
- E-post: gengyuhan@cmu.edu.cn
-
-
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
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Age 60 years or older.
- Not previously diagnosed with dementia.
- Meets the diagnostic criteria for mild cognitive impairment, with Montreal Cognitive Assessment scores adjusted by education level, Mini-Mental State Examination score >= 24, and Activities of Daily Living score < 23.
- Has lived in a nursing home for more than 2 months and plans to continue living there during the study period.
- No hearing impairment; Hearing Handicap Inventory for the Elderly-Screening Version score < 8, and able to hear binaural beats through both ears.
- Conscious and able to cooperate with questionnaires and scale assessments.
- Has not taken medications that may affect cognitive function within 3 to 6 months before the intervention.
Exclusion Criteria:
- Severe physical disease, major organ failure, or advanced malignant tumor.
- Diagnosed depression or other psychiatric disorders.
Withdrawal Criteria:
- Serious adverse events during the study, such as falls, disease recurrence, discomfort caused by the intervention audio, death, or other conditions making continued participation unsuitable.
- Voluntary withdrawal from the study.
Removal Criteria:
- Incomplete data resulting in missing information.
- Missing three or more intervention sessions within 2 weeks without following intervention instructions.
- Receiving other treatments or interventions related to cognitive function during the trial.
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: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Binaural Beats Plus Old Songs Group
Participants will listen to old songs embedded with 10-Hz alpha-frequency binaural beats through headphones once daily for 30 minutes for 14 consecutive days.
|
Participants in the intervention group will listen to old songs embedded with 10-Hz alpha-frequency binaural beats through headphones once daily for 30 minutes for 14 consecutive days.
The old songs will be selected according to older adults' music preferences.
|
|
Aktiv komparator: Old Songs Group
Participants will listen to the same type of old songs without binaural beats through headphones once daily for 30 minutes for 14 consecutive days.
|
Participants in the control group will listen to old songs without binaural beats through headphones once daily for 30 minutes for 14 consecutive days.
The old songs will be selected according to older adults' music preferences.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Montreal Cognitive Assessment Score
Tidsramme: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
|
Cognitive function will be assessed using the Montreal Cognitive Assessment.
The total score ranges from 0 to 30, with higher scores indicating better cognitive function.
|
Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
|
|
Change in Digit Span Test Score
Tidsramme: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
|
Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
|
|
|
Change in Stroop Color-Word Test Score
Tidsramme: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
|
Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
|
|
|
Change in Trail Making Test Score
Tidsramme: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
|
Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
|
|
|
Change in Pittsburgh Sleep Quality Index Score
Tidsramme: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
|
Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
|
|
|
Change in Geriatric Anxiety Scale Score
Tidsramme: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
|
Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
|
|
|
Change in Geriatric Depression Scale-15 Score
Tidsramme: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
|
Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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 (Faktiske)
15. juni 2026
Primær fullføring (Antatt)
1. september 2026
Studiet fullført (Antatt)
20. september 2026
Datoer for studieregistrering
Først innsendt
27. juli 2026
Først innsendt som oppfylte QC-kriteriene
27. juli 2026
Først lagt ut (Faktiske)
30. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Lunshen [2025] 239
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