- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07435220
Robot-Assisted Meditation for Older Adults With Cognitive Concerns
Investigating the Effects of Haptic Robot Meditation on Sleep Quality in Older Adults With Cognitive Concerns
While traditional app-based mindfulness meditation programs relying solely on audio guidance have shown potential benefits for older adults, the apps often face challenges such as low compliance. Participants frequently report difficulties in maintaining focus during meditation sessions, which can limit its effectiveness in improving outcomes such as stress reduction and sleep quality. Recognizing these limitations, this study explores whether a haptic-enabled handheld robot can enhance meditation practices by providing both haptic and audio guidance. The robot, designed to foster sustained attention and encourage rhythmic breathing, may offer a novel, multidimensional approach that addresses compliance issues and supports deeper engagement in mindfulness meditation.
The study primarily seeks to answer the question: Does robot-guided meditation, combining both haptic and audio guidance, improve the sleep quality of older adults living alone with subjective cognitive decline more effectively than traditional audio-based mindfulness meditation guidance? Furthermore, the study examines a secondary question: Is the effect of robot-guided meditation on sleep quality mediated by reductions in stress? By investigating these questions, the research aims to offer insights into whether haptic-enabled meditation technology can overcome common barriers to mindfulness practices among older adults and serve as an innovative tool to improve physical, emotional, and cognitive well-being.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
While traditional app-based mindfulness meditation programs relying solely on audio guidance have shown potential benefits for older adults, the apps often face challenges such as low compliance. Participants frequently report difficulties in maintaining focus during meditation sessions, which can limit its effectiveness in improving outcomes such as stress reduction and sleep quality. Recognizing these limitations, this study explores whether a haptic-enabled handheld robot can enhance meditation practices by providing both haptic and audio guidance. The robot, designed to foster sustained attention and encourage rhythmic breathing, may offer a novel, multidimensional approach that addresses compliance issues and supports deeper engagement in mindfulness meditation.
The study primarily seeks to answer the question: Does robot-guided meditation, combining both haptic and audio guidance, improve the sleep quality of older adults living alone with subjective cognitive decline more effectively than traditional audio-based mindfulness meditation guidance? Furthermore, the study examines a secondary question: Is the effect of robot-guided meditation on sleep quality mediated by reductions in stress? By investigating these questions, the research aims to offer insights into whether haptic-enabled meditation technology can overcome common barriers to mindfulness practices among older adults and serve as an innovative tool to improve physical, emotional, and cognitive well-being.
Aim 1: This aim will evaluate the effectiveness of robot-guided meditation, a novel approach that combines haptic feedback and audio guidance, in reducing stress levels among older adults living alone with subjective cognitive decline. Stress levels will be measured using the Perceived Stress Scale (PSS). The haptic-enabled intervention aims to enhance focus, engagement, and stress reduction more effectively than audio-only methods, addressing challenges like low adherence and distraction in mindfulness practices.
Aim 2: This aim explores the role of stress reduction as a mediator between robot-guided meditation and improved sleep quality. Sleep will be assessed through the Pittsburgh Sleep Quality Index (PSQI) and Fitbit data, measuring self-reported and objective sleep outcomes like restlessness and time awake. The study will clarify whether reduced stress drives better sleep outcomes.
Aim 3: This aim will examine adherence to and usability of the robot-guided meditation intervention. Adherence will be tracked through self-reported practice logs and usage data. By evaluating how older adults interact with and engage with this technology, the study will provide insights into the practicality of implementing this approach for individuals experiencing subjective cognitive decline.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chien-Ming Huang, PhD
- Phone Number: 404-932-6567
- Email: chienming.huang@jhu.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants have subjective cognitive decline, assessed using the Subjective Cognitive Decline Questionnaire (SCD-Q)
Exclusion Criteria:
- Participants do not have dementia or mild cognitive impairment.
- To exclude significant cognitive impairment, investigators will utilize the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Robot-Guided
A handheld robot provides daily mindfulness meditation sessions that include both haptic and audio guidance.
|
A handheld robot provides daily mindfulness meditation sessions that include both haptic and audio guidance.
|
|
Active Comparator: Audio-Guided
Participants use a standard mindfulness meditation app offering audio-only daily meditation sessions.
|
Participants use a standard mindfulness meditation app offering audio-only daily meditation sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks
|
Pittsburgh Sleep Quality Index (PSQI).
The total score range 0 to 21, where a score greater than 5 indicates poor sleep quality.
A higher score indicates worse sleep quality.
|
Baseline, 4 weeks, 8 weeks, 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stress level as assessed by the Perceived Stress Scale (PSS)
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks
|
Perceived Stress Scale (PSS).
The total score ranges 0 to 40.
Low Stress: 0-13; Moderate Stress: 14-26; High Stress: 27-40.
A higher score indicates a higher level of perceived stress.
|
Baseline, 4 weeks, 8 weeks, 12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence
Time Frame: From enrollment up to end of treatment at 8 weeks
|
Adherence is defined as the number of days a participant completes the required meditation sessions.
Adherence will be tracked through self-reported practice logs and usage data.
|
From enrollment up to end of treatment at 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chien-Ming Huang, PhD, Johns Hopkins University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00549847
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cognitive Impairment
-
Stanford UniversityRecruitingMild Cognitive Impairment | Subjective Cognitive ImpairmentUnited States
-
University of EdinburghNHS LothianNot yet recruitingCognitive Impairment | Anesthesia | Cognitive Impairment, Mild | Anesthesia Brain Monitoring | Cognitive Impairment, Progressive | Anesthesia Depth MonitoringUnited Kingdom
-
Fondazione Don Carlo Gnocchi OnlusUniversity of Florence; Consorzio di Bioingeneria e Informatica Medica; Gutenberg...CompletedCognitive Dysfunction | Mild Cognitive Impairment | Vascular Cognitive ImpairmentItaly
-
University of California, Los AngelesCompletedMild Cognitive Impairment (MCI) | Age-associated Cognitive ImpairmentUnited States
-
Universidad de ZaragozaRecruitingMild Cognitive Impairment | Randomized Controlled Trial | Subjective Cognitive ImpairmentSpain
-
BaycrestCentre for Aging and Brain Health InnovationUnknownNeurocognitive Disorders | Cognitive Dysfunction | Mental Disorder | Cognitive Impairment, Mild | Cognitive Disorder | Nonamnestic Mild Cognitive ImpairmentCanada
-
Region SkaneLund University; Berry LabCompletedMemory Impairment | Cognitive Impairment, MildSweden
-
Sunnybrook Health Sciences CentreRecruitingMild Cognitive Impairment | Vascular Cognitive ImpairmentCanada
-
University of GeorgiaApplied Universal Dynamics, Corp.; Van Robotics, Inc.Active, not recruitingRobot-assisted Cognitive Training for Lonely Older Adults With Mild Cognitive Impairment (MCI) (MCI)Cognitive Change | Aging | Cognitive Impairment, MildUnited States
-
University of HawaiiRecruitingMild Cognitive Impairment | Subjective Cognitive ImpairmentUnited States
Clinical Trials on Robot-Guided Meditation
-
University of California, San FranciscoCompleted
-
Shanghai Mental Health CenterSchool of Biomedical Engineering, Shanghai Jiao Tong UniversityRecruitingMeditation | MindfulnessChina
-
Mayo ClinicNot yet recruiting
-
Wake Forest University Health SciencesMind and Life Institute, Hadley, MassachusettsCompleted
-
Shifa International HospitalCompletedType 1 Diabetes MellitusPakistan
-
National Yang Ming Chiao Tung University HospitalCompleted
-
Midwestern UniversityCompletedStress, Psychological | Well-being | Meditation | Resilience, Psychological | MindfulnessUnited States
-
University of GaziantepNot yet recruitingCoronary Artery Disease | Anxiety | Cardiac Surgery | Surgical Stress Response | Postoperative StressTurkey (Türkiye)