RECRUITING

Multi-sensory Intervention Room Application (MIRA) Device in the NSICU

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this research study is to determine the safety, feasibility, and efficacy of a device, MIRA, on the physical, mental, and cognitive health of Neurosciences Intensive Care Unit (NSICU) patients. The study device is a Multi-Sensory Stimulation Device named MIRA, which uses commercially available hardware and builds off the SOLUNA software created by Studio Elsewhere, which produces audio and visual immersive experiences. The current device, Model M1, is a prototype developed for sole investigational purposes of this study and is not commercially available. Participants, who will be patients and staff of the NSICU, will complete questionnaires regarding safety, feasibility, and efficacy. The research team will enroll 20 patient and 15 staff participants. The trial is expected to last 12 months.

Official Title

Safety, Feasibility, and Efficacy of a Bio-experiential Intervention, Multi-sensory Intervention Room Application (MIRA), During Neurosciences ICU Stay

Quick Facts

Study Start:2024-08-25
Study Completion:2025-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06509815

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Current employee at NSICU
  2. * Aged \>/= 18
  3. * Currently admitted to the Mount Sinai Hospital NSICU for any diagnosis OR a Legally Authorized Representative (LAR) for the patient, and expected to stay for at least 48 hours
  4. * Provision of signed and dated informed consent form (ICF)
  5. * Stated willingness to comply with all study procedures and availability for the duration of the study
  6. * Aged \>/= 18
  7. * Any sex or gender identity
  8. * Currently admitted to the Mount Sinai Hospital NSICU for any diagnosis OR a Legally Authorized Representative (LAR) for the patient, and expected to stay for at least 48 hours
  9. * Not a Mount Sinai NSICU patient
  10. * No LAR present and unable to consent
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Christopher Santiago
CONTACT
646-656-4937
christopher.santiago@mountsinai.org

Principal Investigator

Neha Dangayach
PRINCIPAL_INVESTIGATOR
Principal Investigator

Study Locations (Sites)

Mount Sinai Hospital
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Neha Dangayach, PRINCIPAL_INVESTIGATOR, Principal Investigator

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-25
Study Completion Date2025-05

Study Record Updates

Study Start Date2024-08-25
Study Completion Date2025-05

Terms related to this study

Keywords Provided by Researchers

  • Post Intensive Care Syndrome
  • Bio-Experiential Space
  • Biophilic Design

Additional Relevant MeSH Terms

  • Post Intensive Care Syndrome