Binaural Beats for Cognitive Function in Older Adults With Mild Cognitive Impairment in Nursing Homes (BB-MCI)
27 juli 2026 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
60
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Liu Yu Yu Liu, Professor
- Telefonnummer: +8618640068209
- E-post: liuyu@cmu.edu.cn
Studieorter
-
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Liaoning
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Shenyang, Liaoning, Kina, 110030
- Rekrytering
- Jintaiyang Jingguan Elderly Care Apartment
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Kontakt:
- Yuhan Geng
- Telefonnummer: 18018945883
- E-post: gengyuhan@cmu.edu.cn
-
Shenyang, Liaoning, Kina, 110031
- Rekrytering
- Jintaiyang Elderly Care Center, Huanggu Branch
-
Kontakt:
- Yuhan Geng
- Telefonnummer: 18018945883
- E-post: gengyuhan@cmu.edu.cn
-
Shenyang, Liaoning, Kina, 110042
- Rekrytering
- Renai Changwan Elderly Care Home, Dadong District
-
Kontakt:
- Yuhan Geng
- Telefonnummer: 18018945883
- E-post: gengyuhan@cmu.edu.cn
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Montreal Cognitive Assessment Score
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
|
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Change in Geriatric Anxiety Scale Score
Tidsram: 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
|
|
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Change in Geriatric Depression Scale-15 Score
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
15 juni 2026
Primärt slutförande (Beräknad)
1 september 2026
Avslutad studie (Beräknad)
20 september 2026
Studieregistreringsdatum
Först inskickad
27 juli 2026
Först inskickad som uppfyllde QC-kriterierna
27 juli 2026
Första postat (Faktisk)
30 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
30 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Lunshen [2025] 239
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