Clinical Trial

REducing pSychological diSTress To Optimize Recovery of Elderly ICU Survivors and Caregivers (RESTORE-ICU)

Study acronym: RESTORE-ICU
Not Yet Recruiting
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Summary
This research study aims to explore whether a set of simple breathing techniques and guided meditations can improve the psychological well-being and recovery of ICU survivors and their caregivers. ICU survivors and their caregivers often experience high levels of stress, anxiety, and depression after discharge. This study investigates whether practicing Isha Kriya, a guided meditation, and Nadi Shuddhi, a breathing technique, can support their mental health and relationship quality. These practices are delivered through a mobile app or in a group setting. Participants enroll as a caregiver-patient dyad and will engage in these techniques throughout the study. In addition to the practices, brain activity will be recorded using a safe, non-invasive EEG device. The EEG, a lightweight cap with small sensors, measures brainwaves to assess potential changes in brain function and connection. EEG recordings will take place in the hospital during two sessions, each lasting approximately 40 minutes. Participants will also complete short surveys at five time points throughout the study, assessing mood, stress, and relationship quality. Baseline demographic information will be collected, and at the conclusion of the study, a brief interview will be conducted to gather feedback on the experience. The study spans approximately seven weeks, with the overall goal of determining whether these breathing and meditation practices can provide accessible and scalable mental health support for ICU survivors and their caregivers.
Protocol Amendment History 1 change
notable Primary completion pushed: 2026-12 -> 2027-12 2026-07-09
Trial Details
NCT Number NCT06867367
Lead Sponsor Beth Israel Deaconess Medical Center
Conditions Relationship, Family, Well-Being, Psychological
Enrollment 14 participants
Start Date 2026-12
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-08