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NCT05866887

Insomnia Prevention in Children With Acute Lymphoblastic Leukemia

Completed NA Results posted Last updated 6 June 2025
What this trial tests

NA trial testing Sleep ALL Night in Pediatric Acute Lymphoblastic Leukemia in 25 participants. Completed in 5 June 2024.

Timeline
26 September 2023
Primary endpoint
5 June 2024
5 June 2024

Quick facts

Lead sponsorDana-Farber Cancer Institute
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposesupportive care
Enrollment25
Start date26 September 2023
Primary completion5 June 2024
Estimated completion5 June 2024
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Dana-Farber Cancer Institute

Who can join

Adults 4 to 12, any sex, with Pediatric Acute Lymphoblastic Leukemia or Leukemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Enrollment Rate of Participants Primary · At screening, when eligible participants are approached by research staff. Recruitment occurred over a 5-month period.

The primary study outcome of acceptability is defined as the proportion of eligible participants who are approached by research staff who agree to participate in the study, with the cutoff set at ≥30% of eligible participants who are approached agreeing to participate.

GroupValue95% CI
Sleep ALL Night25
Acceptability of Intervention Measure Scale Score Primary · At Week 4

The primary study outcome of acceptability is defined as participants reporting an average score of ≥4 ("Agree") on the Acceptability of Intervention Measure scale, a four-item questionnaire assessing the acceptability of an intervention. The scale uses a 5-point scale with options ranging from Completely Agree (5) to Completely Disagree (1). The average score of all four items was used as the primary outcome. A higher score indicates greater belief that the intervention was acceptable for the participant.

GroupValue95% CI
Sleep ALL Night4.40± 0.63
Intervention Assessment Completion Rate Primary · Up to 1 month after the conclusion of the study period, up to 8 weeks.

The primary study outcome of feasibility is defined as ≥80% of enrolled participants complete the Post-Intervention Assessment.

GroupValue95% CI
Sleep ALL Night22

Sponsor's own description

The goal of this research study is to understand the acceptability and feasibility of the Sleep ALL Night intervention among children with Acute Lymphoblastic Leukemia (ALL) in hopes of improving the discussion of sleep disorders with clinical providers. The name of the intervention used in this research study is: Sleep ALL Night, which is a sleep intervention program comprised of an action plan tool and psychoeducational website.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Pediatric Acute Lymphoblastic Leukemia

Currently open trials in the same condition.

Other Dana-Farber Cancer Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05866887.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing