Insomnia study: Sleep Health Education
Official title Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients
ClinicalTrials.gov ID: NCT06375265
What this study is testing
- What it's testing
- The study wants to learn whether a cognitive‑behavioral therapy for insomnia (CBT‑I) mobile app, used with a wrist sleep monitor, can reduce postoperative delirium and other cognitive problems after surgery.
- Who it's for
- Older adults scheduled for major orthopedic joint surgery who have trouble sleeping.
- What's involved
- Participants are randomly assigned to use a sleep‑improvement app and wear a wrist device that records sleep patterns, while the control group receives usual care. They will attend study visits and complete questionnaires.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility criteria
- 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.
- 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
- 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
- No surgery within 12 months of consented, eligibility will be reassessed if surgery is delayed by more than 3 months
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.