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CompletedNCT03446820Updated Dec 11, 2018

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

An interventional study of hygro cotton sheets in Sleep, sponsored by Mayo Clinic. Completed at 3 sites in United States. Open to female participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-11.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
16
Ages
21 Years to 45 Years
Sex
Female
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Sleep
03

Who can participate

Ages eligible
21 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria. Premenopausal women Age 21-45

Exclusion Criteria History of sleep disorders

04

Study design

Phase
Not applicable
Primary purpose
Other
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Other
    Sleep participants

    Crossover from standard sheets to hygro cotton sheets

    Other: hygro cotton sheets

Interventions

  • Otherhygro cotton sheets

    hygro cotton sheets will be utilized to impact microclimate

05

What researchers measure

Primary outcomes

  1. body temperature

    body temperature collected via body sensors

    Time frame: 1 night

06

Study locations

3 sites
  • Mayo Clinic in Arizona
    Scottsdale, Arizona 85259, United States
  • Mayo Clinic in Florida
    Jacksonville, Florida 32224, United States
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
07

Registry details

Key details

Study ID
NCT03446820
Lead sponsor
Mayo Clinic
Responsible party
Brent A. Bauer (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Feb 27, 2018
Start date
Jun 1, 2018
Primary completion
Sep 30, 2018
Completion
Dec 1, 2018
Last update
Dec 11, 2018

Study contacts

Brent A Bauer
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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