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

NCT02117271 | Completed

• 1 other identifier: 0068
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Obstructive Sleep Apnea

Keywords

obstructive sleep apnea; treatment; placebo; appearance; skin quality

Outcome Measures

Primary Outcomes (1)

• appearance

  Patients will be rated for attractiveness (very unattractive to very attractive), health (very sick to very healthy), tiredness (not at all tired to very tired) and age

  1 month

Secondary Outcomes (1)

• skin quality

  1 month

Study Arms (2)

nasal dilator strip

PLACEBO COMPARATOR

Breathe Right ® nasal dilator strip used during sleep

Other: Breathe Right ®

continuous positive airway pressure

EXPERIMENTAL

nasal continuous positive airway pressure used during sleep

Device: continuous positive airway pressure

Interventions

continuous positive airway pressure DEVICE

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

Also known as: Philips Respironics, System One, REMstar Pro

continuous positive airway pressure

Breathe Right ® OTHER

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

Also known as: GlaxoSmithKline Brasil Ltda.

nasal dilator strip

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• severe sleep apnea (apnea-hypopnea index \> 30)
• Epworth Sleepiness Scale score \> 10

You may not qualify if:

• previous treatment for sleep-disordered breathing
• previous diagnosis of chronic diseases that interfere with sleep patterns
• history the chronic use of alcohol, sedatives or drugs of abuse, in the last month.

Sponsors & Collaborators

• Nucleo Interdisciplinar da Ciencia do Sono: lead

Study Sites (1)

Nucleo Interdisciplinar Da Ciencia Do Sono

São Paulo, São Paulo, 05401-000, Brazil

Location

Related Publications (1)

• Yagihara F, Lorenzi-Filho G, Santos-Silva R. Patients With OSA Are Perceived as Younger Following Treatment With CPAP. Chest. 2019 Sep;156(3):553-561. doi: 10.1016/j.chest.2019.03.015. Epub 2019 Mar 27.

  PMID: 30926396 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• GERALDO L FILHO, MD, PHD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 10, 2014
• First Posted: April 17, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: March 29, 2017

Record last verified: 2017-03

Locations

BR (1)