NCT07435220

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

1.4 years

First QC Date

February 20, 2026

Last Update Submit

February 20, 2026

Conditions

Cognitive ImpairmentSleep

Keywords

MeditationRobotOlder adultsCognitive concernsRobot-Guided InterventionAudio-Guided Control

Outcome Measures

Primary Outcomes (1)

  • Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)

    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 Outcomes (1)

  • Stress level as assessed by the Perceived Stress Scale (PSS)

    Baseline, 4 weeks, 8 weeks, 12 weeks

Other Outcomes (1)

  • Adherence

    From enrollment up to end of treatment at 8 weeks

Study Arms (2)

Robot-Guided

EXPERIMENTAL

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

Behavioral: Robot-Guided Meditation

Audio-Guided

ACTIVE COMPARATOR

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

Behavioral: Audio-Guided Control

Interventions

Robot-Guided MeditationBEHAVIORAL

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

Robot-Guided
Audio-Guided ControlBEHAVIORAL

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

Audio-Guided

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Participants have subjective cognitive decline, assessed using the Subjective Cognitive Decline Questionnaire (SCD-Q)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Chien-Ming Huang, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chien-Ming Huang, PhD

CONTACT

404-932-6567chienming.huang@jhu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2026

First Posted

February 27, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

February 27, 2026

Record last verified: 2026-02