RECRUITING

Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients

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 Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST) is a pilot randomized, controlled, singled-blinded (participant) trial in major orthopedic joint surgery patients that will build on a previously clinically tested cognitive behavioral therapy for insomnia (CBT-I) mobile application paired with a wearable device (wrist actigraphy).

Official Title

A Pilot Study of Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST)

Quick Facts

Study Start:2024-10-31
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06375265

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:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adults ≥ 65 years old
  2. 2. Scheduled for an elective orthopedic total joint replacement procedure (knee/hip) with an anticipated stay of ≥48 hours
  3. 3. At least mild insomnia (ISI score of ≥10 on telephone screening)
  4. 4. Stable sleep-affecting medications in the prior month (by clinical review)
  5. 5. Own a smart phone
  6. 6. Willingness to use the dCBT-I app and actigraphy.
  1. 1. Current or previous CBT-I
  2. 2. Rapidly progressive illnesses/life expectancy \<6 months
  3. 3. Active psychosis/suicidal ideation
  4. 4. Irregular shift work/sleep patterns
  5. 5. Moderate-severe sleep apnea (apnea/hypopnea index ≥15) per chart review
  6. 6. Sleep disorders other than insomnia or apnea
  7. 7. Cognitive impairment (diagnosis of dementia)

Contacts and Locations

Study Contact

Andrea Castillo, MD
CONTACT
4695094163
analecastillo2001@gmail.com
Andrea Castillo, BS
CONTACT
4695094163
acastillo17@mgh.harvard.edu

Principal Investigator

Lei Gao, MD
PRINCIPAL_INVESTIGATOR
Mass. General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Lei Gao, MD, PRINCIPAL_INVESTIGATOR, Mass. General Hospital

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 Date2024-10-31
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2024-10-31
Study Completion Date2026-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Insomnia
  • Postoperative Delirium
  • Delayed Neurocognitive Recovery
  • Postoperative Neurocognitive Disorder