This Study Assesses the Impact of Different Sheets on Body Temperature and Sleep
Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT03446820
Collaborator
(none)
16
3
1
6
5.3
0.9
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
16 participants
Intervention Model:
Sequential Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Sleep Quality and Microclimate Study
Actual Study Start Date
:
Jun 1, 2018
Actual Primary Completion Date
:
Sep 30, 2018
Actual Study Completion Date
:
Dec 1, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Sleep participants Crossover from standard sheets to hygro cotton sheets |
Other: hygro cotton sheets
hygro cotton sheets will be utilized to impact microclimate
|
Outcome Measures
Primary Outcome Measures
- body temperature [1 night]
body temperature collected via body sensors
Eligibility Criteria
Criteria
Ages Eligible for Study:
21 Years
to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria. Premenopausal women Age 21-45
Exclusion Criteria History of sleep disorders
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Arizona | Scottsdale | Arizona | United States | 85259 |
| 2 | Mayo Clinic in Florida | Jacksonville | Florida | United States | 32224 |
| 3 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Brent A Bauer, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Brent A. Bauer,
Principal Investigator,
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT03446820
Other Study ID Numbers:
- 18-000832
First Posted:
Feb 27, 2018
Last Update Posted:
Dec 11, 2018
Last Verified:
Dec 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No