InsomniaSLEEP-BOOSTNCT06375265
Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients
A study testing digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) and Sleep Health Education in people with Insomnia and Postoperative Delirium, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Insomnia, Postoperative Delirium, Delayed Neurocognitive Recovery
- What is being tested?
- digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) and Sleep Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Adults ≥ 65 years old
- Scheduled for an elective orthopedic total joint replacement procedure (knee/hip)
- 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.
Who cannot join
- Current or previous CBT-I exposure in the last 6 months prior to the start of the study
- Rapidly progressive illnesses/life expectancy <6 months
- Active psychosis/suicidal ideation
- Irregular shift work/sleep patterns
- Moderate-severe sleep apnea (apnea/hypopnea index ≥15) without CPAP compliance per chart review
- Sleep disorders other than insomnia or apnea
Show all 9Show fewer
- Cognitive impairment (diagnosis of dementia)
- 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)
- No surgery within 12 months of consented, eligibility will be reassessed if surgery is delayed by more than 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Lei Gao, MD, 6178882941, lgao@mgh.harvard.edu
Andrea Castillo, BS, 4695094163, acastillo17@mgh.harvard.edu
About this study
Official title: A Pilot Study of Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST)
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).
Read the detailed description
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).
- Conditions
- Insomnia, Postoperative Delirium, Delayed Neurocognitive Recovery, Postoperative Neurocognitive Disorder
- Being tested
- digital Cognitive Behavioral Therapy for Insomnia (dCBT-I), Sleep Health Education
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)Behavioural
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 EducationBehavioural
Sleep Health Education materials provided
| Study group | Role | What they receive |
|---|---|---|
| Digital CBT-I | Experimental | 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. Receives: Behavioral: digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) |
| Sleep Health Education | Active comparator | Preoperative sleep health education materials Receives: Behavioral: Sleep Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: 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)
Measured: At screening, baseline, every session of the dCBT-I/control 3-week intervention period, 2 weeks, 1- and 3-months after surgery
Secondary outcomes (10)
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).
Measured: 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)
Measured: 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.
Measured: After dCBT-I intervention during Review session ~1 days to 1 week before surgery.
Cognition
Telephonic Montreal Cognitive Assessment (tMoCA) test to assess cognition
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: From postoperative day 1 to postoperative day 3
Delayed Neurocognitive Recovery
Using cognitive change from baseline (1 standard deviation from the mean).
Measured: At 1-months after surgery
Postoperative Neurocognitive Disorders (NCD)
Using cognitive change from baseline (1 standard deviation from the mean).
Measured: At 3-months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start15 Jan 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Kun Hu, Massachusetts General Hospital
- Investigators
- Lei Gao, MD, Study chair, Massachusetts General HospitalKun Hu, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375265
- Sponsor's protocol ID
- 2024P000780-1
- Acronym
- SLEEP-BOOST
- Status last verified
- Sep 2026
- First submitted
- 7 Apr 2024
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Charles AE, Castillo Suarez AA, Chhajed M, Jimenez Gallardo M, Sanchez Valdes K, Li P, Hu K, Wong PM, Winkelman J, Gao L. Perioperative sleep optimisation and brain health in older adults (SLEEP-BOOST): protocol for a randomised controlled trial. BMJ Open. 2026 May 28;16(5):e116526. doi: 10.1136/bmjopen-2026-116526.
PubMed 42209013
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST)
- ClinicalTrials.gov ID
- NCT06375265
- Acronym / sponsor ID
- SLEEP-BOOST / 2024P000780-1
- Conditions
- Insomnia, Postoperative Delirium, Delayed Neurocognitive Recovery, Postoperative Neurocognitive Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital CBT-I | Experimental | Behavioral: digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)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. |
| Sleep Health Education | Active comparator | Behavioral: Sleep Health EducationPreoperative sleep health education materials |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Adults ≥ 65 years old
- Scheduled for an elective orthopedic total joint replacement procedure (knee/hip)
- 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.
Key exclusion criteria (9 listed)
- Current or previous CBT-I exposure in the last 6 months prior to the start of the study
- Rapidly progressive illnesses/life expectancy <6 months
- Active psychosis/suicidal ideation
- Irregular shift work/sleep patterns
- Moderate-severe sleep apnea (apnea/hypopnea index ≥15) without CPAP compliance per chart review
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)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. | Behavioural | Digital CBT-I |
| Sleep Health EducationSleep Health Education materials provided | Behavioural | Sleep Health Education |
Primary outcome
Adherence: CBT-I
Time frame: After dCBT-I intervention during Review session ~1 day to 3 weeks before surgery.
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)
Adherence: Sleep Diary/Actigraphy
Time frame: Throughout the study 3-4 weeks before surgery, and 2 weeks, 1 month and 3 months after surgery.
The number of days of completed sleep diaries and actigraphy will be recorded.
Adherence: Homework Completion
Time frame: After dCBT-I intervention during Review session ~1 day to 3 weeks before surgery.
The amount of time spent on CBT-I homework will be recorded.
Insomnia Severity
Time frame: At screening, baseline, every session of the dCBT-I/control 3-week intervention period, 2 weeks, 1- and 3-months after surgery
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)
10 secondary outcomes
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
Time frame: After dCBT-I intervention during Review session ~1 day to 1 week before surgery.
Satisfaction with intervention
Time frame: After dCBT-I intervention during Review session ~1 days to 1 week before surgery.
Cognition
Time frame: At baseline and 2 weeks, 1- and 3-months after surgery
Pain severity and Function
Time frame: At baseline, end of the dCBTI/control intervention pre-surgery and 2 weeks, 1- and 3-months after surgery
Mood/Anxiety
Time frame: At baseline and 1- and 3-months after surgery
Postoperative Delirium Incidence
Time frame: From postoperative day 1 to postoperative day 3
Postoperative Delirium Severity
Time frame: From postoperative day 1 to postoperative day 3
Delayed Neurocognitive Recovery
Time frame: At 1-months after surgery
Postoperative Neurocognitive Disorders (NCD)
Time frame: At 3-months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Derived from this study: PubMed 42209013Charles AE, Castillo Suarez AA, Chhajed M, Jimenez Gallardo M, Sanchez Valdes K, Li P, Hu K, Wong PM, Winkelman J, Gao L. Perioperative sleep optimisation and brain health in older adults (SLEEP-BOOST): protocol for a randomised controlled trial. BMJ Open. 2026 May 28;16(5):e116526. doi: 10.1136/bmjopen-2026-116526.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lei Gao, MD study chair
Massachusetts General Hospital
Kun Hu, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) and Sleep Health Education in people with Insomnia and Postoperative Delirium, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Castillo, BS (4695094163, acastillo17@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence: CBT-I (time frame: After dCBT-I intervention during Review session ~1 day to 3 weeks before surgery.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06375265, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.