MedDataX Logo

This Study Assesses the Impact of Different Sheets on Body Temperature and Sleep

NCT ID: NCT03446820

Last Updated: 2018-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2018-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Thermal comfort and subsequent sleep quality will improve with the use of bedding that incorporates thermoregulation technology, in comparison to standard bedding products.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Participants will spend nights sleeping in the residential module of the Well Living Lab. Participants will cross over from normal sheets to hygro cotton sheets to assess impact of different sheet types on microclimate (e.g. temperature) and the impact on sleep quality.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Intervention Model

SEQUENTIAL

Participants will be randomly assigned to sleep in the residential module of the Well Living Lab. One week will be with standard sheets, followed by one week of hygro cotton sheets.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sleep participants

Crossover from standard sheets to hygro cotton sheets

Group Type OTHER

hygro cotton sheets

Intervention Type OTHER

hygro cotton sheets will be utilized to impact microclimate

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

hygro cotton sheets

hygro cotton sheets will be utilized to impact microclimate

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Inclusion Criteria. Premenopausal women Age 21-45

Exclusion Criteria History of sleep disorders
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Brent A. Bauer

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Brent A Bauer

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

18-000832

Identifier Type: -

Identifier Source: org_study_id