- 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 Perceived Stress 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 programs often face challenges such as low engagement. 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. To address these limitations, this study examines whether a haptic robot that provides both tactile and audio guidance can enhance meditation. The robot's expansion and contraction movements help users pace and sustain rhythmic breathing, while gentle vibrations signal phase transitions without disrupting concentration. These haptic features are intended to anchor attention and support a more embodied practice.
The study primarily seeks to answer the following questions: Does a haptic enabled meditation intervention reduce perceived stress in older adults living alone with subjective cognitive decline more effectively than an audio only mindfulness meditation guidance provided by a non-moving robot? To what extent does enhanced attentional anchoring mediate the intervention's effect on perceived stress in this population? By addressing these questions, the research aims to determine whether haptic enabled meditation technology can overcome common barriers to mindfulness practice among older adults and serve as an innovative tool to reduce perceived stress, and ultimately improve their sleep quality and 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: Non-Moving Robot
Participants use the same robot, which remains stationary (no haptic movement) and provides audio-only daily meditation sessions.
|
Participants use the same robot, which remains stationary (no haptic movement) and provides audio-only daily meditation sessions.
|
What is the study measuring?
Primary 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
|
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
|
Secondary 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
|
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
|
|
Anxiety as assessed by the Generalized Anxiety Disorder scale (GAD-7)
Time Frame: Baseline, week 4, week 8
|
Generalized Anxiety Disorder scale (GAD-7).
The total score ranges from 0 to 21.
A score of 10 or higher is often used as a cutoff suggesting clinically significant anxiety.
A higher score indicates worse anxiety.
|
Baseline, week 4, week 8
|
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
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