Vascular Photobiomodulation on Sleep Qualityand Stress

Sleep Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05415163
• Other study ID #: PMBQS
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: December 20, 2022

Study information

• Verified date: October 2022
• Source: University of Nove de Julho
• Contact: Lara Motta, PhD
• Phone: 11998829511
• Email: larajmotta[@]terra.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 20, 2022
• Est. primary completion date: November 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Parasomnias
• Sleep Disorder
• Sleep Wake Disorders
• Stress Disorder

Intervention

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.

Locations

Country	Name	City	State
Brazil	Lara Motta	São Roque	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of sleep	Quality of sleep evaluated by Pittsburgh Sleep Quality Index	five weeks