Feasibility of the Use of Weighted Blankets to Improve Sleep Among Patients With Hematological Malignancies

Last updated: February 16, 2026
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Hematologic Neoplasms

Neoplasms

Hematological Disorders

Treatment

Weighted Blanket

Clinical Study ID

NCT06584955
2024-0464
NCI-2024-07498
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Outpatient at MD Anderson Cancer Center

  2. Adult patients ≥ 18 years

  3. Diagnosis of hematological malignancy

  4. ESAS Sleep>/=4

  5. Performance status as measured by Eastern Cooperative Oncology Practice group (ECOG)score of 2 or below

Exclusion

Exclusion Criteria:

  1. Platelet count of 25 or below

  2. History of seizures/intracranial metastasis/ sleep apnea/restless legsyndrome/paralysis

  3. Weight less than 150 lbs.

  4. Attending physician assessment of prognosis with expected life expectancy of <1 month

  5. Patients who are unable to tolerate their blankets/sheets in the night due tomedical conditions such as pain, peripheral neuropathy, night sweats, hot flashesetc.

  6. Patients with difficulty breathing, disorders of poor circulation, fragile skin,rash, or open wounds, or by those who are claustrophobic or cleithrophobic.

  7. Prior use of weighted blankets within the past 1-year

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Weighted Blanket
Phase:
Study Start date:
May 01, 2025
Estimated Completion Date:
July 31, 2027

Study Description

Primary Objective:

To determine the feasibility of using weighted blankets to improve Sleep Disturbances (SD) for patients with hematological malignancies in an outpatient setting.

Secondary Objectives:

To explore if weighted blanket use improves sleep as assessed by the ESAS sleep question. A positive response is defined by at least a one-point reduction in ESAS sleep between baseline and day 7 +/-2 days.

To explore if weighted blanket use during a 14-day period improves Insomnia Severity Index (ISI) score.

To explore the response rate in anxiety, where response is defined as a minimum of one-point change in the ESAS anxiety score, between baseline and day 7 +/-2 days after the use of weighted blankets.

To explore if patients are satisfied with the use of weighted blankets as determined by a positive response to at least 2 of the 5 patient satisfaction questions.

To assess safety using NCI CTCAE v5

Connect with a study center

  • The University of Texas MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

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