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Vascular Photobiomodulation on Sleep Qualityand Stress

Primary Purpose

Stress Disorder, Sleep Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
vascular photobiomodulation
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorder focused on measuring stress, sleep disorder, photobiomodulation, laser therapy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Lara MottaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

vascular photobiomodulation

photbiomodulation-sham

Arm 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.

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.

Outcomes

Primary Outcome Measures

Quality of sleep
Quality of sleep evaluated by Pittsburgh Sleep Quality Index

Secondary Outcome Measures

Full Information

First Posted
June 8, 2022
Last Updated
October 4, 2022
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT05415163
Brief Title
Vascular Photobiomodulation on Sleep Qualityand Stress
Official Title
Effect of Vascular Photobiomodulation on Sleep Quality, Relaxation and Stress Control: Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
November 10, 2022 (Anticipated)
Study Completion Date
December 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorder, Sleep Disorder
Keywords
stress, sleep disorder, photobiomodulation, laser therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
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
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
vascular photobiomodulation
Arm Type
Experimental
Arm 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.
Arm Title
photbiomodulation-sham
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
vascular photobiomodulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of sleep
Description
Quality of sleep evaluated by Pittsburgh Sleep Quality Index
Time Frame
five weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lara Motta, PhD
Phone
11998829511
Email
larajmotta@terra.com.br
Facility Information:
Facility Name
Lara Motta
City
São Roque
State/Province
SP
ZIP/Postal Code
18133-399
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lara Motta, PhD
Phone
11998829511

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Vascular Photobiomodulation on Sleep Qualityand Stress

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