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Robot-Assisted Meditation for Older Adults With Cognitive Concerns

No phase Interventional Cognitive Impairment Sleep

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Robot-Guided Meditation, Audio-Guided Control.
Who it may be relevant to
Registry conditions: Cognitive Impairment, Sleep. Basic parameters: 65 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • Behavioral Robot-Guided Meditation
    A handheld robot provides daily mindfulness meditation sessions that include both haptic and audio guidance.
  • Behavioral Audio-Guided Control
    Participants use a standard mindfulness meditation app offering audio-only daily meditation sessions.

Primary outcome measures

  • Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks]
Secondary outcome measures (1)
  • Stress level as assessed by the Perceived Stress Scale (PSS) [Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07435220 · IRB00549847

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗