NCT03446820

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

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

First Submitted

Initial submission to the registry

February 21, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 11, 2018

Status Verified

December 1, 2018

Enrollment Period

4 months

First QC Date

February 21, 2018

Last Update Submit

December 8, 2018

Conditions

Sleep

Outcome Measures

Primary Outcomes (1)

  • body temperature

    body temperature collected via body sensors

    1 night

Study Arms (1)

Sleep participants

OTHER

Crossover from standard sheets to hygro cotton sheets

Other: hygro cotton sheets

Interventions

hygro cotton sheetsOTHER

hygro cotton sheets will be utilized to impact microclimate

Sleep participants

Eligibility Criteria

Age21 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPremenopausal women
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Study Officials

  • Brent A Bauer

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 21, 2018

First Posted

February 27, 2018

Study Start

June 1, 2018

Primary Completion

September 30, 2018

Study Completion

December 1, 2018

Last Updated

December 11, 2018

Record last verified: 2018-12

Locations

US(3)