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The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer
NCT05780814 · View on ClinicalTrials.gov ↗
Study Summary
The investigators propose a randomized controlled clinical trial in 250 women with a history of early stage breast cancer who are overweight or obese with insomnia to test whether a brief, cognitive-behavioral intervention for insomnia (CBT-I) prior to behavioral weight loss (CBT-I+BWL) is superior to a sleep education control (EDU) condition followed by behavioral weight loss (EDU+BWL). The investigators will measure outcomes at baseline, 8 weeks (after completing CBT-I or EDU and prior to BWL), and at 3, 6, and 12 months.
Conditions Studied
Interventions
- BEHAVIORAL Cognitive-Behavioral Therapy for Insomnia (CBT-I)
- BEHAVIORAL Sleep Education Control (EDU)
Study Locations (4)
Maryland
- Sidney Kimmel Comprehensive Cancer Center, the Avon Foundation Breast Center at Johns Hopkins — Baltimore
- Johns Hopkins Bayview — Baltimore
- Johns Hopkins Kimmel Cancer Center at Greenspring Station — Lutherville
District of Columbia
- Sibley Memorial Hospital — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2024-02-01 |
| Est. Completion | 2028-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05780814
The ClinicalTrials.gov registry entry for NCT05780814 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,517 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions — of which Cognitive-Behavioral Therapy for Insomnia (CBT-I) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05780814 reports 4 study locations spanning 2 distinct geographic areas — top geographies include Maryland, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05780814 about?
NCT05780814 is a clinical study titled "The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer". The investigators propose a randomized controlled clinical trial in 250 women with a history of early stage breast cancer who are overweight or obese with insomnia to test whether a brief, cognitive-behavioral intervention for insomnia (CBT-I) prior to behavioral weight loss (CBT-I+BWL) is superior ...
What is the current status of trial NCT05780814?
This trial is currently recruiting. It is a NA study. The enrollment target is 250 participants. The study started on 2024-02-01. Estimated completion is 2028-12-31.
What conditions does trial NCT05780814 study?
This clinical trial studies the following conditions: Breast Cancer, Insomnia, Weight Gain. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05780814?
The interventions under investigation include: Cognitive-Behavioral Therapy for Insomnia (CBT-I) (BEHAVIORAL), Sleep Education Control (EDU) (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05780814?
This trial is sponsored by Johns Hopkins University, which has 1,517 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05780814 being conducted?
This trial has 4 study locations across District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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