An interventional study of digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) and Sleep Health Education in Insomnia, Postoperative Delirium and Delayed Neurocognitive Recovery, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
Among 18 studies in Sleep Initiation and Maintenance Disorders by Massachusetts General Hospital — 4 open to participants now, 5 under way, none of them phase 3. Sleep Initiation and Maintenance Disorders · Massachusetts General Hospital.
Among the 18 studies in Sleep Initiation and Maintenance Disorders by Massachusetts General Hospital, this one is the 10th largest by planned enrollment of the 17 interventional ones that give a count, is one of 2 that started in 2025, is one of 12 with no phase, and was the 14th registered.
2,726 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 728 are open to participants now.
Browse Sleep Initiation and Maintenance Disorders studies →4 of the 18 studies in Sleep Initiation and Maintenance Disorders by Massachusetts General Hospital are open now, in 1 country. Recruiting first, the newest first:
Massachusetts General Hospital · Sites in United States
Ages 65+
Massachusetts General Hospital · Sites in United States
Massachusetts General Hospital · Sites in United States
Ages 18+
By country, each count listing its studies:
Of the 388 Sleep Initiation and Maintenance Disorders studies recruiting now, 152 (39%) set no upper age limit and 206 (53%) stop at 75 or younger; 59 take children under 18; 108 take healthy volunteers.
This study: 65 Years and older · all sexes · no healthy volunteers.
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18 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 2 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is below the median of 68 across 2,353 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Median enrollment 60 across the 17 interventional studies, 30 across the 1 observational. Of the 12 that completed or were terminated, 5 (42%) have results posted.
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Massachusetts General Hospital is the lead sponsor of 2,588 studies on the registry; 446 are open to participants now.
Of its 223 completed or terminated interventional studies of FDA-regulated products, 168 (75%) have results posted.
2 of the studies in Sleep Initiation and Maintenance Disorders by Massachusetts General Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06181643Massachusetts General HospitalInnovating CBT-I for Cancer Survivors: An Optimization Trial | 2026-11-15 |
| NCT06751992Massachusetts General HospitalNeurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients | 2027-05-01 |
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Among the 18 studies in Sleep Initiation and Maintenance Disorders by Massachusetts General Hospital, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
CBT-I is the frontline treatment for insomnia but is not considered for preoperative care of older surgical patients with insomnia who are at risk of perioperative neurocognitive disorders associated with sleep/circadian dysfunction. We propose to determine if digital CBT-I (dCBT-I) is feasible for treating older surgical patients with insomnia symptoms and to examine the effects of dCBT-I on sleep, cognitive trajectory, mood, pain, activity, and function after surgery. 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 CBT-I mobile application paired with a wearable device (wrist actigraphy).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
5. Own a smart phone 6. Willingness to use the dCBT-I app and actigraphy.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Preoperative digital CBT-I with the CBT-I Coach app for up to 4 weekly sessions and postoperative booster sessions at 2 weeks and 1 month after surgery.
Behavioral: digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)
Preoperative sleep health education materials
Behavioral: Sleep Health Education
Preoperative hybrid intervention (in-person or via phone/video) over 4 weeks, and at 2 weeks, and 1 month after surgery using content from the CBT-I Coach app from Veteran Affairs.
Sleep Health Education materials provided
Adherence: CBT-I
A Patient Adherence Form developed by the Veterans Affairs CBT-I Training Program will be used to assess adherence to the protocol. A mean adherence score across six domains showing good psychometric properties will be derived (0-24; higher represents more adherent)
Time frame: After dCBT-I intervention during Review session ~1 day to 3 weeks before surgery.
Adherence: Sleep Diary/Actigraphy
The number of days of completed sleep diaries and actigraphy will be recorded.
Time frame: Throughout the study 3-4 weeks before surgery, and 2 weeks, 1 month and 3 months after surgery.
Adherence: Homework Completion
The amount of time spent on CBT-I homework will be recorded.
Time frame: After dCBT-I intervention during Review session ~1 day to 3 weeks before surgery.
Insomnia Severity
The Insomnia Severity Index (ISI) questionnaire will be used to determine the quality of sleep for patients (0 to 28; higher represents more severe insomnia symptoms)
Time frame: At screening, baseline, every session of the dCBT-I/control 3-week intervention period, 2 weeks, 1- and 3-months after surgery
Sleep Quality
The Pittsburgh Sleep Quality Index (PSQI) questionnaire will be used to assess subjective sleep quality in patients (range 0 to 21; higher scores indicate worse sleep quality).
Time frame: At baseline, every session of the dCBT-I/control 3-week intervention period, 2 weeks, 1- and 3-months after surgery
Utility
A 16-item digital intervention utility questionnaire will be used to assess patient usage of the app (0-64; higher represents more perceived utility)
Time frame: After dCBT-I intervention during Review session ~1 day to 1 week before surgery.
Satisfaction with intervention
A 9-item survey will be used to assess which elements of the app were most helpful and the likelihood the patient would recommend it to family/friends.
Time frame: After dCBT-I intervention during Review session ~1 days to 1 week before surgery.
Cognition
Telephonic Montreal Cognitive Assessment (tMoCA) test to assess cognition
Time frame: At baseline and 2 weeks, 1- and 3-months after surgery
Pain severity and Function
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain will measure functional pain severity
Time frame: At baseline, end of the dCBTI/control intervention pre-surgery and 2 weeks, 1- and 3-months after surgery
Mood/Anxiety
The Geriatric Depression Scale-15 will be used to assess the mood of the patients (0-15; higher represents more severe mood/depression symptoms). Generalize Anxiety Disorder 7 (GAD-7; 0-21; higher represents more anxiety symptoms)
Time frame: At baseline and 1- and 3-months after surgery
Postoperative Delirium Incidence
The Confusion Assessment Method (3D-CAM) will be used to monitor signs of delirium in patients.
Time frame: From postoperative day 1 to postoperative day 3
Postoperative Delirium Severity
The Confusion Assessment Method (CAM)-Severity assessment will be used to monitor signs of delirium severity in patients.
Time frame: From postoperative day 1 to postoperative day 3
Delayed Neurocognitive Recovery
Using cognitive change from baseline (1 standard deviation from the mean).
Time frame: At 1-months after surgery
Postoperative Neurocognitive Disorders (NCD)
Using cognitive change from baseline (1 standard deviation from the mean).
Time frame: At 3-months after surgery
Circadian Rest-Activity Rhythms
Motor activity will be recorded on wrist actigraphy watches to derive amplitude, acrophase, interdaily stability, intradaily variability, most active 10h (M10), least active 5h (L5), relative amplitude (RA), fractal motor activity regulation (FMAR).
Time frame: At baseline, immediately after the intervention, and 2 weeks, 1- and 3-months after surgery
Ancillary Data Collection
Collection of blood samples from participant
Time frame: Before baseline session, on surgery day, and once on post-operative days 1-3
Started Jan 2025 (actual). Primary completion is estimated for Sep 2026, 20 months after the start.
Of 1,211 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's planned 20 months is above that.
Counting every sponsor, half of 1,289 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
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