Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:39 AM
Study NCT ID:
NCT07435220
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robot-Assisted Meditation for Older Adults With Cognitive Concerns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-20', 'studyFirstSubmitDate': '2026-02-20', 'studyFirstSubmitQcDate': '2026-02-20', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adherence', 'timeFrame': 'From enrollment up to end of treatment at 8 weeks', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'Baseline, 4 weeks, 8 weeks, 12 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Stress level as assessed by the Perceived Stress Scale (PSS)', 'timeFrame': 'Baseline, 4 weeks, 8 weeks, 12 weeks', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Meditation', 'Robot', 'Older adults', 'Cognitive concerns', 'Robot-Guided Intervention', 'Audio-Guided Control'], 'conditions': ['Cognitive Impairment', 'Sleep']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nThe 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.\n\nAim 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.\n\nAim 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.\n\nAim 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants have subjective cognitive decline, assessed using the Subjective Cognitive Decline Questionnaire (SCD-Q)\n\nExclusion Criteria:\n\n* Participants do not have dementia or mild cognitive impairment.\n* To exclude significant cognitive impairment, investigators will utilize the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA).'}, 'identificationModule': {'nctId': 'NCT07435220', 'briefTitle': 'Robot-Assisted Meditation for Older Adults With Cognitive Concerns', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Investigating the Effects of Haptic Robot Meditation on Sleep Quality in Older Adults With Cognitive Concerns', 'orgStudyIdInfo': {'id': 'IRB00549847'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Robot-Guided', 'description': 'A handheld robot provides daily mindfulness meditation sessions that include both haptic and audio guidance.', 'interventionNames': ['Behavioral: Robot-Guided Meditation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Audio-Guided', 'description': 'Participants use a standard mindfulness meditation app offering audio-only daily meditation sessions.', 'interventionNames': ['Behavioral: Audio-Guided Control']}], 'interventions': [{'name': 'Robot-Guided Meditation', 'type': 'BEHAVIORAL', 'description': 'A handheld robot provides daily mindfulness meditation sessions that include both haptic and audio guidance.', 'armGroupLabels': ['Robot-Guided']}, {'name': 'Audio-Guided Control', 'type': 'BEHAVIORAL', 'description': 'Participants use a standard mindfulness meditation app offering audio-only daily meditation sessions.', 'armGroupLabels': ['Audio-Guided']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Chien-Ming Huang, PhD', 'role': 'CONTACT', 'email': 'chienming.huang@jhu.edu', 'phone': '404-932-6567'}], 'overallOfficials': [{'name': 'Chien-Ming Huang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}