Digital sleep optimization for older surgical patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot trial investigates the feasibility of using a digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) application, combined with a wearable device, to improve sleep and cognitive outcomes in older patients undergoing major orthopedic joint surgery. The study aims to address insomnia symptoms in patients aged 65 and older, who are at risk for postoperative neurocognitive disorders. Participants will be randomized to receive either the dCBT-I intervention or sleep health education, with outcomes measured in terms of sleep quality, cognitive function, mood, pain, activity, and overall recovery post-surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults ≥ 65 years old
2. Scheduled for an elective orthopedic total joint replacement procedure (knee/hip)
3. At least mild insomnia (ISI score of ≥10 on telephone screening or RedCap screening questionnaire)

5\. Own a smart phone 6. Willingness to use the dCBT-I app and actigraphy.

Exclusion Criteria:

1. Current or previous CBT-I exposure in the last 6 months prior to the start of the study
2. Rapidly progressive illnesses/life expectancy \<6 months
3. Active psychosis/suicidal ideation
4. Irregular shift work/sleep patterns
5. Moderate-severe sleep apnea (apnea/hypopnea index ≥15) without CPAP compliance per chart review
6. Sleep disorders other than insomnia or apnea
7. Cognitive impairment (diagnosis of dementia)
8. Initiation, discontinuation, or dose change of sleep-affecting prescription medications within 1 month prior to study start or during the intervention period; not excluded if stable sleep-affecting medications in the prior month (by clinical review)
9. No surgery within 12 months of consented, eligibility will be reassessed if surgery is delayed by more than 3 months

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Kun Hu, PhD — Massachusetts General Hospital
• Study coordinator: Andrea Castillo, BS
• Email: acastillo17@mgh.harvard.edu
• Phone: 4695094163

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• How anesthesia type affects thinking after bariatric sleeve surgery

  This observational study tests whether intravenous anesthesia or inhalational anesthesia leads to different cognitive outcomes after sleeve gastrectomy in adults with obesity.

  Recruiting Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital · Istanbul, Sancaktepe · NCT07637357

• Perioperative transcranial photobiomodulation to see if it helps older adults recover brain function after surgery

  This trial tests whether applying light therapy to the brain around the time of surgery can reduce delayed brain recovery in older patients with pre-existing cognitive decline.

  Recruiting Peking University First Hospital · Beijing, Beijing Municipality · NCT07736092

• Repetitive transcranial magnetic stimulation to improve post-surgery thinking and memory in older adults

  This trial will test whether repetitive transcranial magnetic stimulation (rTMS) given around the time of surgery helps older adults with mild-to-moderate cognitive impairment keep their thinking and memory after non-cardiac operations.

  Recruiting Peking University First Hospital · Beijing, Beijing Municipality and 2 other locations · NCT06482749

• Analyzing serum indicators in elderly patients after gastrointestinal surgery

  This study is testing how certain blood markers in older patients who have gastrointestinal surgery relate to whether they experience confusion after surgery and any long-term thinking problems.

  Recruiting Xuanwu Hospital, Beijing · Beijing · NCT06466096

• Analyzing serum indexes in elderly spinal surgery patients with postoperative delirium

  This study is trying to see if there are differences in blood test results between older patients who experience confusion after spinal surgery and those who don’t, to better understand their recovery.

  Recruiting Xuanwu Hospital, Beijing · Beijing · NCT06466083

• Predicting postoperative delirium and cognitive issues in elderly patients

  This study is trying to find out what factors can predict confusion and memory problems after surgery in older patients to help doctors make better decisions and improve their care.

  Recruiting Xuanwu Hospital, Beijing · Beijing · NCT06423547

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.