Vascular Photobiomodulation on Sleep Qualityand Stress

Not Applicable

Recruiting

• Conditions: Sleep Disorder; Stress Disorder
• Interventions: Procedure: vascular photobiomodulation

• Registration Number: NCT05415163
• Lead Sponsor: University of Nove de Julho

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.

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2022-06-08
• Study First Submitted QC: 2022-06-08
• Study First Posted: 2022-06-10
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-04
• Last Update Posted: 2022-10-05
• Primary Completion: 2022-11-10
• Study Completion: 2022-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
photbiomodulation-sham	vascular photobiomodulation	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.
vascular photobiomodulation	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.

Primary Outcome Measures

Name	Time	Method
Quality of sleep	five weeks	Quality of sleep evaluated by Pittsburgh Sleep Quality Index

Trial Locations

Locations (1)

Lara Motta; 🇧🇷 São Roque, SP, Brazil