NCT04273789

Brief Summary

Far infrared light (FIR, 5.6-1000 µm) penetrates our skin and reaches the underlying tissue up to 4 cm and promotes widening of the blood vessels (vasodilation). This results in increased blood flow in the tissue under the skin, without heating up the skin itself. Increased blood flow allows more oxygen to reach the muscles and more metabolic waste products to be transported away from the muscles. Studies assessing clothing containing an FDA approved ceramic particles covered yarn that reflect FIR light showed delayed onset muscle pain decreased and a reduction in inflammatory markers in professional athletes. The aim of this study is to investigate the effect of far infrared reflecting sleepwear on night-time recovery and Sleep in a broader population, namely physically active adults (non-professional).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

February 17, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2020

Completed
Last Updated

August 3, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

February 12, 2020

Last Update Submit

July 31, 2020

Conditions

Outcome Measures

Primary Outcomes (5)

  • Change in time of flight during jump (s)

    Time of flight during jump is the time between offset and landing. The influence of the intervention is determined by comparing the values 72h post exercise bout of each week.

    72 hours post exercise bout in week 1 and week 2

  • Change in maximum isometic leg force (N)

    Maximum isometic leg force will be measured while participants are lying on their back with knees 90 Degrees bend. They press against a vertically mounted force plate. The average of 3 measurements separated by 1 minute break is used.The influence of the intervention is determined by comparing the values 72h post exercise bout of each week.

    72 hours post exercise bout in week 1 and week 2

  • Change in leg circumference (m)

    Circumference of the tight while standing will be measured using a measurement tape. The average of 3 measurements separated by 1 minute break is used. The influence of the intervention is determined by comparing the values 72h post exercise bout of each week.

    72 hours post exercise bout in week 1 and week 2

  • Change in knee range of motion (Degrees)

    Active range of motion of the knee while lying on the stomach is determined using a goniometer. The influence of the intervention is determined by comparing the values 72h post exercise bout of each week.

    72 hours post exercise bout in week 1 and week 2

  • Change in muscle soreness (rating on visual analog scale)

    Subjectively experienced delayed onset muscle soreness measured using a visual analog scale. The change in soreness over time is of interest, as well as the influence of the intervention. The influence of the intervention is determined by comparing the values 1, 2, 3, 4, 5, 6 and 7 post exercise bout of both weeks.

    1, 2, 3, 4, 5, 6 days post exercise bout in week 1 and week 2

Secondary Outcomes (1)

  • Activity during night

    1, 2, 3, 4, 5, 6 days post exercise bout in week 1 and week 2

Study Arms (2)

far infrared reflecting sleepwear

EXPERIMENTAL

Sleepwear (shorts + tshirt) with far infrared reflecting ceramic print produced by Dagsmejan AG (Zurich, Switzerland)

Device: Far infrared reflecting sleepwear

Placebo sleepwear

PLACEBO COMPARATOR

Sleepwear (shorts + tshirt)

Device: Placebo sleepwear

Interventions

100% microlyocell sleepwear (shorts + shirt) with a ceramic print that reflects far infrared light (FIR, 5.6-1000 µm) emitted by the human body. Since FIR active garments are not powered, but reflect recycle light energy emitted by the body of the wearer, they have irradiances between 0.1-5 mW/cm\^2.

far infrared reflecting sleepwear

100% microlyocell sleepwear (shorts + shirt)

Placebo sleepwear

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physically active (\>3h of sports per week)
  • BMI \< 25

You may not qualify if:

  • Sleep problems (assessed using standardized questionnaire included in entrance questionnaire)
  • Cardiovascular problems (self-reported in entrance questionnaire)
  • Sensitive skin/allergies that present on a skin level (self-reported in entrance questionnaire)
  • Knee pain while exercising (self-reported in entrance questionnaire)
  • Night shift work during study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SMS lab

Zurich, 8092, Switzerland

Location

Study Officials

  • Robert Riener, Prof. Dr.

    Swiss FIT

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Prior to the study participants are informed about the study protocol, measurements and risks, but not about the study purpose. Debriefing is conducted verbally, as well as in written form and includes the signing of a second consent form. The experimenters conducting the measurements and analysis is not aware of the randomization. Unblinding is planned for interim analysis after 10 datasets have been collected and at study end.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2020

First Posted

February 18, 2020

Study Start

February 17, 2020

Primary Completion

July 2, 2020

Study Completion

July 2, 2020

Last Updated

August 3, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

We consider uploading the actigraphy measurements to the ETH Research Collection database to make them available to other investigators.

Time Frame
The data will be ulpoaded to the research collection after study completion and is available there for a period of 15 years.
Access Criteria
Open Access
More information

Locations