Evidence map›Paper›PMID 32195961›Full record

ArticleMedicine2020

Photobiomodulation by low-level laser therapy in patients with obstructive sleep apnea: Study protocol clinical trial (SPIRIT compliant).

Fernanda Cristina Ferreira de Camargo, José Roberto DeMoura, Felipe Xerez Cepeda, Marilia de Almeida Correia, Reginaldo Ceolin Nascimento, Lucas Fortes-Queiroz, Fabiana Gonçalves Ferreira, Renata Kelly da Palma, Maria Fernanda Hussid, Maria Cristina Chavantes and 1 more

Open access · goldAbstract readComparative StudyClinical Trial Protocol
In one paragraph

Article in Medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.0field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 1 institution in 1 country.

Fernanda Cristina Ferreira de CamargoGraduate Program in Medicine, University Nove de Julho.
José Roberto DeMouraGraduate Program in Medicine, University Nove de Julho.
Felipe Xerez CepedaGraduate Program in Medicine, University Nove de Julho.
Marilia de Almeida CorreiaGraduate Program in Medicine, University Nove de Julho.
Reginaldo Ceolin NascimentoGraduate Program in Medicine, University Nove de Julho.
Lucas Fortes-QueirozGraduate Program in Medicine, University Nove de Julho.
Fabiana Gonçalves FerreiraGraduate Program in Medicine, University Nove de Julho.
Renata Kelly da PalmaGraduate Program in Medicine, University Nove de Julho.
Maria Fernanda HussidGraduate Program in Medicine, University Nove de Julho.
Maria Cristina ChavantesGraduate Program in Medicine, University Nove de Julho.
Ivani Credidio TrombettaGraduate Program in Medicine, University Nove de Julho.
Universidade Nove de Julho · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Obstructive sleep apnea (OSA) increases morbidity and mortality and it is associated with an increased cardiovascular risk. The gold standard treatment for OSA is positive airway pressure therapy (CPAP). However, it is an expensive treatment and several patients do not adapt to CPAP. GOAL: The researchers will verify the effects of low-level laser therapy (LLLT) on OSA, when applied to the soft palate and on the tongue base.

methodsThe researchers will select individuals of both sexes aged 30 to 60 years old who are sedentary and that present a high risk of OSA by the Berlin questionnaire. The evaluations pre and post interventions will be polysomnography; anthropometric and body composition measurements (Bioimpedance); metabolic syndrome risk factors (International Diabetes Federation); physical capacity (VO2 peak at the cardiopulmonary exercise test, CPET); endothelial function (flow-mediated dilatation, FMD); autonomic control (heart rate variability and sympathovagal balance). Those diagnosed with moderate and severe OSA (apnea/hypopnea index, AHI ≥15 events/h) will be invited to participate in the study and they will be randomized into 2 groups: LLLT treatment or placebo (C). The LLLT group will receive applications at 8 points on the soft palate and on the base of the tongue for 8 seconds for each point. The applications of LLLT will occur twice a week, with a minimum interval of 2 days between the applications for 2 months, when using a Therapy Plus NS 13678 Laser. The C group will have similar applications, but with the device turned off. EXPECTED

resultsIn the individuals with OSA, photobiomodulation through LLLT will decrease the AHI. Additionally, when LLLT is applied in the oral cavity, a highly vascularized region, this may cause improvements in the vascular function and in the autonomic and hemodynamic control. ETHICS AND DISSEMINATION: This protocol was approved by the Research Ethics Committee of the Nove de Julho University, São Paulo, Brazil, on the date of March 11, 2019 (CAAE: 06025618.2.0000.5511 - Acceptance Number: 3.191.077). This trial has been registered with the Brazilian Registry of Clinical Trials (REBEC TRIAL RBR-42v548). This study is not yet recruiting. Issue date: November 4, 2019.

Indexed as

AdultBrazilExercise TestFemaleHumansLow-Level Light TherapyMaleMetabolic SyndromeMiddle AgedMouthPalate, SoftPolysomnographyRandomized Controlled Trials as TopicRisk FactorsSleep Apnea, ObstructiveTongue

Identifiers

PMID32195961
PMCPMC7220119
OpenAlexW3011906822

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.