NCT06584955

Brief Summary

The goal of this clinical research study is to learn about the effects of weighted blankets on sleep quality in patients with blood cancers. Weighted blankets are heavier blankets that contain inner weight beads. The deep pressure stimulation induced by these blankets can have a calming effect.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
15mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
May 2025Jul 2027

First Submitted

Initial submission to the registry

September 3, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 5, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

2.2 years

First QC Date

September 3, 2024

Last Update Submit

February 16, 2026

Conditions

Hematological Malignancies

Outcome Measures

Primary Outcomes (1)

  • Safety and Adverse Events (AEs)

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Through study completion; an average of 1 year

Study Arms (2)

Patients more than 200 pounds

EXPERIMENTAL
Other: Weighted Blanket

Patients between 150-200 pounds

EXPERIMENTAL
Other: Weighted Blanket

Interventions

Weighted BlanketOTHER

Participants will be given a weighted blanket

Patients between 150-200 poundsPatients more than 200 pounds

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Outpatient at MD Anderson Cancer Center
  • Adult patients ≥ 18 years
  • Diagnosis of hematological malignancy
  • ESAS Sleep\>/=4
  • Performance status as measured by Eastern Cooperative Oncology Practice group (ECOG) score of 2 or below

You may not qualify if:

  • Platelet count of 25 or below
  • History of seizures/intracranial metastasis/ sleep apnea/restless leg syndrome/paralysis
  • Weight less than 150 lbs.
  • Attending physician assessment of prognosis with expected life expectancy of \<1 month
  • Patients who are unable to tolerate their blankets/sheets in the night due to medical conditions such as pain, peripheral neuropathy, night sweats, hot flashes etc.
  • Patients with difficulty breathing, disorders of poor circulation, fragile skin, rash, or open wounds, or by those who are claustrophobic or cleithrophobic.
  • Prior use of weighted blankets within the past 1-year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Santhosshi Narayanan, MBBS

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2024

First Posted

September 5, 2024

Study Start

May 1, 2025

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

February 17, 2026

Record last verified: 2026-02

Locations

US(1)