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Clinical Trials/NCT05415163
NCT05415163
Recruiting
Not Applicable

Effect of Vascular Photobiomodulation on Sleep Quality, Relaxation and Stress Control: Randomized Controlled Clinical Trial

University of Nove de Julho1 site in 1 country72 target enrollmentJune 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress Disorder
Sponsor
University of Nove de Julho
Enrollment
72
Locations
1
Primary Endpoint
Quality of sleep
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

Randomized clinical trial to evaluate the effect of vascular photobiomodulation on sleep quality, relaxation and stress when compared to placebo.

Detailed Description

The quality of sleep is directly linked to the quality of human life. Irradiation of blood in the transcutaneous vascular technique is believed to decrease blood viscosity and platelet aggregation; activates superoxide dismutase; promotes increased oxygen content and stimulates microcirculation, it also stimulates increased serotonin production and cortisol reduction. Serotonin functions include sleep initiation, mood improvement, anxiety and depression. Therefore, the objective of the present project is to evaluate the effect of ILIB on salivary biomarkers related to stress and sleep. Therefore, participants with problems related to sleep quality will be selected and divided into 2 groups, group 1 undergoing ILIB Therapy twice a week for 30 minutes and group 2 the same frequency and time of application, but with placebo equipment. At the end of 10 sessions, salivary biomarkers related to stress and sleep and the patients' perception will be evaluated through specific questionnaires on the effect of ILIB on sleep, stress and relaxation.

Registry
clinicaltrials.gov
Start Date
June 1, 2022
End Date
December 20, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lara Jansiski Motta

PhD

University of Nove de Julho

Eligibility Criteria

Inclusion Criteria

  • poor sleep quality.
  • Participants who for at least six months have had poor sleep quality (score \> 5 points), measured using the PSQI,

Exclusion Criteria

  • use medications or perform treatments that may affect the sleep cycle
  • treatment for hypertension
  • attention deficit disorder,
  • diabetes.

Outcomes

Primary Outcomes

Quality of sleep

Time Frame: five weeks

Quality of sleep evaluated by Pittsburgh Sleep Quality Index

Study Sites (1)

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