Vascular Photobiomodulation on Sleep Qualityand Stress

University of Nove de Julho

Status: Enrolling

Conditions: Stress Disorder; Sleep Disorder

Treatments: Procedure: vascular photobiomodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05415163

PMBQS

Details and patient eligibility

About

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

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups

vascular photobiomodulation

Experimental group

Description:

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.

Treatment:

Procedure: vascular photobiomodulation

photbiomodulation-sham

Sham Comparator group

Description:

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.

Treatment:

Procedure: vascular photobiomodulation