Vascular Photobiomodulation on Sleep Qualityand Stress
Effect of Vascular Photobiomodulation on Sleep Quality, Relaxation and Stress Control: Randomized Controlled Clinical Trial
1 other identifier
interventional
72
1 country
1
Brief Summary
Randomized clinical trial to evaluate the effect of vascular photobiomodulation on sleep quality, relaxation and stress when compared to placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2022
Shorter than P25 for not_applicable
1 active site
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
Study Start
First participant enrolled
June 1, 2022
CompletedFirst Submitted
Initial submission to the registry
June 8, 2022
CompletedFirst Posted
Study publicly available on registry
June 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2022
CompletedOctober 5, 2022
October 1, 2022
5 months
June 8, 2022
October 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of sleep
Quality of sleep evaluated by Pittsburgh Sleep Quality Index
five weeks
Study Arms (2)
vascular photobiomodulation
EXPERIMENTALLaser will be applied with the spot located in the radial artery of the participant's arm (right or left), and fixed to the wrist with a specific bracelet.
photbiomodulation-sham
SHAM COMPARATORThe device will be placed with the spot located in the radial artery of the participant's arm (right or left), and fixed to the wrist with a specific bracelet no laser apllied.
Interventions
application of photobiomodulation with the device O Ecco ILIB (Eccofibras, São Paulo, Brazil) containing its red wavelength 660 nm ± 10 nm and power 100 mW, with an application time of 30 minutes. The device will be positioned with the spot located in the radial artery of the participant's arm (right or left), and fixed to the wrist with a specific bracelet.
Eligibility Criteria
You may qualify if:
- poor sleep quality.
- Participants who for at least six months have had poor sleep quality (score \> 5 points), measured using the PSQI,
You may not qualify if:
- use medications or perform treatments that may affect the sleep cycle
- treatment for hypertension
- asthma,
- attention deficit disorder,
- diabetes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lara Motta
São Roque, São Paulo, 18133-399, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- The photobiomodulation application devices are identical in both groups and in the placebo group the device will not emit light, only the sound signal. Both participant and researcher will wear protective eyewear and will not know which equipment is the active or placebo. Only a researcher external to the procedure will know which equipment is in each group
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
June 8, 2022
First Posted
June 10, 2022
Study Start
June 1, 2022
Primary Completion
November 10, 2022
Study Completion
December 20, 2022
Last Updated
October 5, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share