Vascular Photobiomodulation on Sleep Qualityand Stress

• Sponsor: University of Nove de Julho (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05415163
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 14.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Stress Disorder; Sleep Disorder	Procedure: vascular photobiomodulation	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: The photobiomodulation application devices are identical in both groups and in the placebo group the device will not emit light, only the sound signal. Both participant and researcher will wear protective eyewear and will not know which equipment is the active or placebo. Only a researcher external to the procedure will know which equipment is in each group
• Primary Purpose: Treatment
• Official Title: Effect of Vascular Photobiomodulation on Sleep Quality, Relaxation and Stress Control: Randomized Controlled Clinical Trial
• Actual Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Jul 10, 2022
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Quality of sleep [five weeks]

   Quality of sleep evaluated by Pittsburgh Sleep Quality Index

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lara Motta	São Roque	SP	Brazil	18133-399

Sponsors and Collaborators

• University of Nove de Julho

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lara Jansiski Motta, PhD, University of Nove de Julho
• ClinicalTrials.gov Identifier: NCT05415163
• Other Study ID Numbers: PMBQS
• First Posted: Jun 10, 2022
• Last Update Posted: Jun 10, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Lara Jansiski Motta, PhD, University of Nove de Julho: stress; sleep disorder; photobiomodulation; laser therapy
• Additional relevant MeSH terms: Sleep Wake Disorders; Parasomnias; Disease

Study Results

No Results Posted as of Jun 10, 2022