Impact of Weighted Blankets on Sleep Quality

NCT06842797 | Recruiting

• 1 other identifier: 2507/05-02-2025
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Weighted blankets have been used to improve sleep quality in children with neurodevelopmental disorders. It is not known, however, whether weighted blankets can improve overnight sleep in healthy adults and those with poor sleep quality and what is the optimal weight of those blankets for achieving the best results. AIMS: The purpose of the present study is to investigate the effect of 4 different weights of weighted blankets on sleep in participants with low sleep quality.

Conditions

Sleep Problems; Sleep

Keywords

weighted blankets; insomnia; poor sleep; fatigue; alternative medicine

Outcome Measures

Primary Outcomes (1)

• Sleep Efficiency

  Sleep Efficiency is equal to total sleep time over Time spend in bed

  At baseline and at the end of the intervention (overnight sleep - 8 hours).

Secondary Outcomes (2)

• Total sleep time

  At baseline and at the end of the intervention (overnight sleep - 8 hours).

• Insomnia Score

  At baseline and at the end of the intervention (overnight sleep - 8 hours).

Study Arms (4)

Control

SHAM COMPARATOR

The Control condition (CON): Participants will be covered with a non-weighted blanket, of similar material and appearance.

7-Kg Blanket

EXPERIMENTAL

Participants will lay down and be covered with 7 Kg weighted blanket.

Other: Weighted Blanket

9-Kg Blanket

EXPERIMENTAL

Participants will lay down and be covered with 9 Kg weighted blanket.

Other: Weighted Blanket

14-Kg Blanket

EXPERIMENTAL

Participants will lay down and be covered with 14 Kg weighted blanket.

Other: Weighted Blanket

Interventions

Weighted Blanket OTHER

Participants will lie down and be covered with a weighted blanket.

14-Kg Blanket; 7-Kg Blanket; 9-Kg Blanket

Non Weighted Blanket OTHER

Participants will lie down and be covered with normal weight blanket (non-weighted blanket)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Gender defined at birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy individual

You may not qualify if:

• history of mental illness
• history of epilepsy
• any acute or chronic condition that would limit the ability of the patient to participate in the study

Sponsors & Collaborators

• University of Thessaly: lead
• University of Nicosia: collaborator

Study Sites (1)

School of Physical Education, Sports and Dietetics, TEFAA

Trikala, Thessaly, 42100, Greece

RECRUITING

MeSH Terms

Conditions

Parasomnias; Sleep Initiation and Maintenance Disorders; Fatigue

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Georgios Sakkas, PhD

  University of Thessaly

  STUDY CHAIR

Central Study Contacts

Christina Karatzaferi, PhD

CONTACT

+302431047022; ck@uth.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 24, 2025
• Study Start: February 20, 2025
• Primary Completion: June 15, 2025
• Study Completion: September 15, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2026-2027
• Access Criteria: Written request to the PI

Locations

GR (1)