Robot-Assisted Meditation for Older Adults With Cognitive Concerns

NCT07435220 | Not Yet Recruiting

• 1 other identifier: IRB00549847
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cognitive Impairment; Perceived Stress

Keywords

Meditation; Robot; Older adults; Cognitive concerns; Robot-Guided Intervention; Audio-Guided Control

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (2)

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

  Baseline, 4 weeks, 8 weeks

• Anxiety as assessed by the Generalized Anxiety Disorder scale (GAD-7)

  Baseline, week 4, week 8

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

Non-Moving Robot

ACTIVE COMPARATOR

Participants use the same robot, which remains stationary (no haptic movement) and provides audio-only daily meditation sessions.

Behavioral: Audio-Only Robot

Interventions

Robot-Guided Meditation BEHAVIORAL

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

Robot-Guided

Audio-Only Robot BEHAVIORAL

Participants use the same robot, which remains stationary (no haptic movement) and provides audio-only daily meditation sessions.

Non-Moving Robot

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older 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).

Sponsors & Collaborators

• Johns Hopkins University: lead

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Chien-Ming Huang, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chien-Ming Huang, PhD

CONTACT

404-932-6567; chienming.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): November 1, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 31, 2026

Record last verified: 2026-08