Cognitive ImpairmentNCT07435220
Robot-Assisted Meditation for Older Adults With Cognitive Concerns
A study testing Robot-Guided Meditation and Audio-Only Robot in people with Cognitive Impairment and Perceived Stress, run by Johns Hopkins University.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Cognitive Impairment, Perceived Stress
- What is being tested?
- Robot-Guided Meditation and Audio-Only Robot
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2027to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Participants have subjective cognitive decline, assessed using the Subjective Cognitive Decline Questionnaire (SCD-Q)
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cognitive Impairment, Perceived Stress
- Being tested
- Robot-Guided Meditation, Audio-Only Robot
- Keywords
- Meditation, Robot, Older adults, Cognitive concerns, Robot-Guided Intervention, Audio-Guided Control
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-Guided MeditationBehavioural
A handheld robot provides daily mindfulness meditation sessions that include both haptic and audio guidance.
Audio-Only RobotBehavioural
Participants use the same robot, which remains stationary (no haptic movement) and provides audio-only daily meditation sessions.
| Study group | Role | What they receive |
|---|---|---|
| Robot-Guided | Experimental | A handheld robot provides daily mindfulness meditation sessions that include both haptic and audio guidance. Receives: 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. Receives: Behavioral: Audio-Only Robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks, 8 weeks
Secondary outcomes (2)
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.
Measured: Baseline, 4 weeks, 8 weeks
Anxiety as assessed by the Generalized Anxiety Disorder scale (GAD-7)
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.
Measured: Baseline, week 4, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Feb 2027 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chien-Ming Huang, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435220
- Sponsor's protocol ID
- IRB00549847
- Status last verified
- Oct 2026
- First submitted
- 20 Feb 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Haptic Robot Meditation on Perceived Stress in Older Adults With Cognitive Concerns
- ClinicalTrials.gov ID
- NCT07435220
- Acronym / sponsor ID
- IRB00549847
- Conditions
- Cognitive Impairment, Perceived Stress
- Keywords
- Meditation, Robot, Older adults, Cognitive concerns, Robot-Guided Intervention, Audio-Guided Control
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-Guided | Experimental | Behavioral: Robot-Guided MeditationA handheld robot provides daily mindfulness meditation sessions that include both haptic and audio guidance. |
| Non-Moving Robot | Active comparator | Behavioral: Audio-Only RobotParticipants use the same robot, which remains stationary (no haptic movement) and provides audio-only daily meditation sessions. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Participants have subjective cognitive decline, assessed using the Subjective Cognitive Decline Questionnaire (SCD-Q)
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-Guided MeditationA handheld robot provides daily mindfulness meditation sessions that include both haptic and audio guidance. | Behavioural | Robot-Guided |
| Audio-Only RobotParticipants use the same robot, which remains stationary (no haptic movement) and provides audio-only daily meditation sessions. | Behavioural | Non-Moving Robot |
Primary outcome
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.
2 secondary outcomes
Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, 4 weeks, 8 weeks
Anxiety as assessed by the Generalized Anxiety Disorder scale (GAD-7)
Time frame: Baseline, week 4, week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chien-Ming Huang, PhD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing Robot-Guided Meditation and Audio-Only Robot in people with Cognitive Impairment and Perceived Stress, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chien-Ming Huang, PhD (404-932-6567, chienming.huang@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress level as assessed by the Perceived Stress Scale (PSS) (time frame: Baseline, 4 weeks, 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.