Feasibility of the Use of Weighted Blankets to Improve Sl... | NCT06584955

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

NCT06584955

Sponsor

M.D. Anderson Cancer Center

Status

Active, not recruiting

Last Update Posted

Feb 17, 2026Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Hematological Malignancies

Interventions

Weighted Blanket

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2024-07498	Other Identifier	NCI-CTRP Clinical Trials Registry

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2025Actual

Primary Completion Date

Jul 31, 2027Estimated

Completion Date

Jul 31, 2027Estimated

First Submitted Date

Sep 3, 2024

First Submission Date that Met QC Criteria

Sep 3, 2024

First Posted Date

Sep 5, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2026

Last Update Posted Date

Feb 17, 2026Actual

Name	Class
Gabrielles Angel FDN for Cancer Research	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients more than 200 pounds	Experimental		Other: Weighted Blanket
Patients between 150-200 pounds	Experimental		Other: Weighted Blanket

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Weighted Blanket	Other	Participants will be given a weighted blanket	Patients between 150-200 pounds Patients more than 200 pounds

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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 &lt;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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Santhosshi Narayanan, MBBS	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Texas MD Anderson Cancer Center		Houston	Texas	77030	United States

Label	URL
MD Anderson Cancer Center Website	View source

Condition Browse Module

MeSH Terms

ID	Term
D019337	Hematologic Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

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Browse Branches

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