Vascular Photobiomodulation on Sleep Qualityand Stress

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

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

Study Overview

• Status: Recruiting
• Conditions: Sleep Disorder; Stress Disorder
• Intervention / Treatment: Procedure: vascular photobiomodulation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lara Motta, PhD; Phone Number: 11998829511; Email: larajmotta@terra.com.br

Study Locations

• Brazil
  • SP
    • São Roque, SP, Brazil, 18133-399
      • Recruiting
      • Lara Motta
      • Contact: Lara Motta, PhD; Phone Number: 11998829511

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
• asthma,
• attention deficit disorder,
• diabetes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: vascular photobiomodulation; Laser 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.	Procedure: vascular photobiomodulation; 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.
Sham Comparator: photbiomodulation-sham; The 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.	Procedure: vascular photobiomodulation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of sleep	Quality of sleep evaluated by Pittsburgh Sleep Quality Index	five weeks

Collaborators and Investigators

• Sponsor: University of Nove de Julho

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Anticipated): November 10, 2022
• Study Completion (Anticipated): December 20, 2022

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): October 5, 2022
• Last Update Submitted That Met QC Criteria: October 4, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: stress; laser therapy; sleep disorder; photobiomodulation
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Disease; Sleep Wake Disorders; Parasomnias
• Other Study ID Numbers: PMBQS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No