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NCT Number: NCT07435220

Robot-Assisted Meditation for 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.

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Key information

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Robot-Guided Meditation

Behavioral

A handheld robot provides daily mindfulness meditation sessions that include both haptic and audio guidance.

Audio-Guided Control

Behavioral

Participants use a standard mindfulness meditation app offering audio-only daily meditation sessions.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chien-Ming Huang, PhD

CONTACT

[email protected]

404-932-6567

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Investigating the Effects of Haptic Robot Meditation on Sleep Quality in Older Adults With Cognitive Concerns

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 27, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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