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The Treatment of Obstructive Sleep Apnea With Continuous Positive Airway Pressure on Appearance and Age

NCT02117271 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-03-29

No results posted yet for this study

Summary

The investigators hypothesized that the treatment of obstructive sleep apnea (OSA) with continuous positive airway pressure (CPAP) will positively affect the appearance of the patient. The purpose of this study was to compare effects of one month of treatment of CPAP and placebo on appearance of patient with OSA in a randomized and crossover study.

Consecutive sleepy patients with severe OSA were included. The patients underwent three polysomnograms (PSG): first one to confirm OSA and two additional ones using placebo (nasal dilator) and for CPAP titration before starting each treatment period. All patients were randomly included into two treatment groups: 1) placebo use and 2) CPAP use. After one month with the first treatment and 15 days of washout, patients were crossed-over for the second treatment. Photographs from the patients' faces were obtained in the three experimental moments. The photographs were presented in a random order by the Qualtrics Survey Software, and were evaluated online by 704 observers for quantifying healthy appearance (unhealthy to extremely healthy), attractive (unattractive to extremely attractive) and tired (not tired to extremely tired). Apparent age was also rated for each observer. Quantitative evaluations of the skin characteristics of the patients' faces were also carried out at each experimental moment, including the presence of acne, patches, porosity, wrinkles, texture, and skin tone uniformity, through the capture of images by VISIATM System equipment.

During treatment period, the 30 patients (age = 46±9 years, 21 men) wearing placebo intervention on 98% of the nights and adherence to CPAP was 94%, with a mean of 6.0 ± 1.7 hours of use per day of treatment. Observational assessment of the photographs showed that patients were evaluated as being younger after using CPAP (P \<0.001), but no quantitative changes in face skin characteristics were observed compared to the baseline and after the use of placebo.

Sleepy patients with severe OSA had a younger appearance after one month of CPAP treatment.

Conditions

Interventions

DEVICE

continuous positive airway pressure

device to treat obstructive sleep apnea using positive airway pressure with a nasal mask

OTHER

Breathe Right ®

Nasal dilator strip treatment used during sleep to open the nasal airway

Sponsors & Collaborators

  • Nucleo Interdisciplinar da Ciencia do Sono

    lead OTHER

Principal Investigators

  • GERALDO L FILHO, MD, PHD · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02117271 on ClinicalTrials.gov