Recruiting

Educational Sleep Intervention

Sponsor:

Scripps Health

Code:

NCT06590285

Conditions

GVHD

Bone Marrow Transplant Complications

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

App-based Educational Intervention

Study Details

Brief summary:

This randomized, phase I/II, open-label study will investigate the efficacy and safety of an educational sleep intervention vs standard of care in adults undergoing alloHSCT. The randomization target in this pilot phase is 60 patients.

Conditions

GVHD

Bone Marrow Transplant Complications

Study ID

NCT06590285

Start date

Apr 2, 2026

Status verified date

Apr, 2026

Completion date

Nov 1, 2033

Anticipated

Primary completion date

Apr 1, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male or female patients aged 18 or older at the time of study informed consent.
  • Have plan to undergo alloHSCT from any donor source using bone marrow, peripheral blood stem cells, or cord blood. Recipients of non-myeloablative, myeloablative and reduced intensity conditioning are eligible.
  • Patients have access to digital device capable of downloading study app
  • Patients able to read study documents and able to complete informed consent within the study app

Exclusion Criteria:

  • Failed prior alloHSCT within the past 6 months

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Standard of Care Monitoring

Usual care will be undergoing alloHSCT without any additional sleep-related educational interventions.

experimental: App-based Educational Intervention

The intervention is a pioneering, evidence-based educational program designed to optimize sleep and physical activity outcomes in patients undergoing allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT).

Interventions

App-based Educational Intervention

The program's educational content is designed to engage patients in the science of sleep and recovery. Segments like "The Sleep Adventure" demystify complex neurobiological processes in an accessible format, aligning with emerging trends in patient education that focus on engagement and knowledge empowerment. Concurrently, the program's physical activity component is meticulously crafted, offering safe, supportive exercises that correspond with the treatment stages of alloHSCT patients. This aspect draws upon evidence highlighting the importance of sustained physical activity during intensive treatments to enhance overall recovery and quality of life. Additionally, the program comprehensively addresses sleep disturbances, prevalent in HSCT patients, through in-depth exploration and evidence-based, non-pharmacologic management strategies, reflecting the significant impact of sleep quality on patient recovery and long-term health outcomes.

Primary outcome measure

  • Objective Sleep Measurement [ Time Frame: Continuous measurement throughout the study duration (from 2 weeks prior to alloHSCT to 100 days post-alloHSCT) ]

Central Contacts and Locations

Central contacts

Jake New, MD, PhD

858-784-2701new.jacob@scrippshealth.org

Locations

Scripps Health

Recruiting

San Diego, California, United States, 92037

Contacts

Jake New

858-554-8788new.jacob@scrippshealth.org

More Information

Sponsor

Scripps Health

Last update posted

Apr 9, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Scripps Health on 2026-04-09.