NCT06789237

Brief Summary

Daytime napping enhances energy restoration, cognitive function, and memory as well as reducing fatigue and improving overall performance. Weighted blankets have been used for improving sleep quality and as a rehabilitation tool for children with neurodevelopmental disorders. It is not known, however, whether weighted blankets can improve short-duration naps like day-time napping and what is the optimal weight of those blankets for achieving the best results. The purpose of the present study is to investigate for the first time the effect of 4 different weighted blankets on sleep parameters on daytime napping.

Trial Health

87
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
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

February 7, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2025

Completed
Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

January 17, 2025

Last Update Submit

January 23, 2025

Conditions

Sleep Deprivation

Keywords

daytime nappower naps

Outcome Measures

Primary Outcomes (2)

  • Total Sleep Time

    Total Sleep Time is the total amount of sleep time scored during the total recording time

    At the end of the 30 minutes intervention

  • Sleep Efficiency

    Sleep Efficiency is the ration of Total sleep time/Time in bed

    At the end of the 35 minutes intervention

Secondary Outcomes (1)

  • Relaxation Score

    At baseline and after the 30 minutes intervention

Study Arms (4)

Control

SHAM COMPARATOR

For the Control condition (CON), subjects will lie down and be covered with a cotton blanket identical in appearance and material to the weighted blanket but without any extra weight,

Other: non-weighted blanket

7 Kg blanket

EXPERIMENTAL

For the 7 kg condition blanket, subjects will lie down and be covered with a blanket weighing 7 kg

Other: weighted blanket

9 Kg blanket

EXPERIMENTAL

For the 9 kg condition blanket, subjects will lie down and be covered with a blanket weighing 9 kg

Other: weighted blanket

14 Kg blanket

EXPERIMENTAL

For the 14 kg condition blanket, subjects will lie down and be covered with a blanket weighing 14 kg

Other: weighted blanket

Interventions

weighted blanketOTHER

Participants will be covered with a weighted blanket for 30 minutes

14 Kg blanket7 Kg blanket9 Kg blanket
non-weighted blanketOTHER

Participants will be covered with a sham non-weighted blanket for 30 minute

Control

Eligibility Criteria

Age18 Years - 45 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsSex at birth
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Capacity to consent

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Physical Education, Sports and Dietetics, TEFAA

Trikala, Thessaly, GR42100, Greece

Location

Related Publications (2)

  • Mullen B, Champagne T, Krishnamurty S, Dickson D, Gao RX. Exploring the safety and therapeutic effects of deep pressure stimulation using a weighted blanket. Occup Ther Ment Health. 2008;24(1):65-89.

    BACKGROUND

  • Dutheil F, Danini B, Bagheri R, Fantini ML, Pereira B, Moustafa F, Trousselard M, Navel V. Effects of a Short Daytime Nap on the Cognitive Performance: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Sep 28;18(19):10212. doi: 10.3390/ijerph181910212.

    PMID: 34639511BACKGROUND

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Christina Karatzaferi, PhD

    University of Thessaly

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

January 17, 2025

First Posted

January 23, 2025

Study Start

February 7, 2024

Primary Completion

August 15, 2024

Study Completion

November 15, 2024

Last Updated

January 28, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Raw data and study IRB protocol

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
January 2025 - January 2026
Access Criteria
Written request

Locations

GR(1)