- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07690709
Eye-tracking Training for Older Adults
Eye Tracking as an Early Cognitive Intervention for Older Adults With Subjective Memory Complaints
The goal of this clinical trial is to learn if a computerized eye-tracking training program can improve mental health and thinking skills in older adults. The main questions it aims to answer are whether eye-tracking training can lower depressive and anxiety symptoms in older adults, and whether it can improve their ability to control impulses and pay attention.
Researchers will compare older adults who receive eye-tracking training to older adults on a waitlist to see if eye-tracking training leads to greater improvements in mood and thinking skills.
Researchers will randomly assign participants into the experimental group or the waitlist control group. Participants in the experimental group will take part in eye-tracking training three times a week for 18 sessions, over about 1.5 months. Before and after training, participants will answer questions about their mood and take tests of memory, attention, and impulse control. Older adults on the waitlist will complete the same tests but will not receive training until after the study period; they will be offered the same training once their waiting period ends.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Hong Kong, Hongkong, 0000
- Research Center for Neuropsychological Well-being
-
Hong Kong, Hongkong
- International Women's League Neighbourhood Elderly Centre
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Community-dwelling Chinese older adults aged 60 to 80 years
- Able to understand Cantonese/Chinese
- Normal or corrected-to-normal vision
- Willing and able to commit to attending 18 training sessions over the course of the intervention
Exclusion Criteria:
- A history of learning disability, psychiatric disorders, neurological disorders (e.g., head injury or Parkinson's disease), visual and/or hearing impairments, or any other physical disabilities that would affect their performance on neuropsychological assessment or adherence to the intervention
- Prior or concurrent participation in other interventions involving eye-tracking techniques
- Signs of dementia, as indicated by a total score of 18 or below on the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA)
- Inability to commit to the full course of 18 training sessions
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Eye-Tracking Training
Participants receive computerized eye-tracking training for 18 one-hour sessions, three times weekly, over approximately 6 weeks.
|
The intervention is a copyrighted computerized training program using a non-contact eye tracker.
Participants are required to fixate on or trace visual targets across six modules of increasing difficulty to improve attention and inhibitory control.
|
|
Geen tussenkomst: Waitlist control
Participants in this group do not receive eye-tracking training during the study period and complete the same baseline and post-assessment schedule as the experimental group.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Inhibitory control
Tijdsspanne: Baseline and after completion of 18 training sessions (approximately 9 weeks)
|
Inhibitory Control Index (ICI) in the Eriksen Flanker Test
|
Baseline and after completion of 18 training sessions (approximately 9 weeks)
|
|
Sustained attention
Tijdsspanne: Baseline and after completion of 18 training sessions (approximately 9 weeks)
|
Digit Cancellation Index (DCI) in the Digit Cancellation Test
|
Baseline and after completion of 18 training sessions (approximately 9 weeks)
|
|
Depressive symptoms
Tijdsspanne: Baseline and after completion of 18 training sessions (approximately 9 weeks)
|
Depressive symptoms are assessed using the 15-item Chinese version of Geriatric Depressive Scale (CGDS-15).
It is a 15-item self-report scale in which participants answer "Yes" or "No" to whether they experienced each of 15 common depressive symptoms in the past week.
Scores range from 0 to 15, with higher scores indicating more depressive symptoms.
A score of 8 or higher indicates clinically significant depressive symptoms.
|
Baseline and after completion of 18 training sessions (approximately 9 weeks)
|
|
Anxiety symptoms
Tijdsspanne: Baseline and after completion of 18 training sessions (approximately 9 weeks)
|
Anxiety symptoms are assessed using the 10-item Chinese version of Geriatric Anxiety Scale (CGAS-10).
It is a 10-item self-report measure of anxiety symptoms in older adults.
Higher scores indicate greater severity of anxiety symptoms.
|
Baseline and after completion of 18 training sessions (approximately 9 weeks)
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2022.625
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .