The Treatment of Obstructive Sleep Apnea With Continuous Positive Airway Pressure on Appearance and Age
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

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.
    

Detailed description: 
      Introduction: A previous study showed that sleep deprived people were perceived as less
      healthy, less attractive, and more tired than after a normal night's sleep (Axelsson et al.,
      Beauty sleep: experimental study on the perceived health and attractiveness of sleep deprived
      people. BMJ 2010;341:c6614). The investigators believe that likewise sleep deprivation,
      patients with OSA also are perceived as less attractive, tired, healthy and look older than
      your age. the investigators therefore hypothesized that the treatment of OSA with continuous
      positive airway pressure (CPAP) 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.

      Methods:The investigators included 30 consecutive patients of both genders, aged between 30
      and 60 years, referred to the sleep clinic of the Heart Institute (InCor) of University of
      Sao Paulo, with a history of snoring, excessive sleepiness, and with severe OSA confirmed by
      polysomnography. Patients were excluded if presenting previous treatment for sleep-disordered
      breathing, previous diagnosis of chronic diseases that interfere with sleep patterns and
      history the chronic use of alcohol, sedatives or drugs of abuse, in the last month.

      Patients were randomized into two treatment groups: 1) Placebo arm - use of nasal dilator
      strip; and 2) CPAP arm - use of CPAP. At the first night of each treatment the patients were
      submitted to a polysomnography with nasal strip (placebo arm) or to CPAP titration (CPAP
      arm). After one month of treatment in the first randomized arm, patients were submitted to
      two weeks without treatment (washout period). After washout period, patients were assigned to
      the treatment crossover, i.e., patients in group 1) receiving CPAP therapy and patients in
      Group 2) receiving placebo treatment, during a period of one additional month. Excessive
      sleepiness (Epworth Sleepiness Scale) and quality of life (Functional Outcomes of Sleep
      Questionnaire - FOSQ) were evaluated in the three experimental times: baseline (immediately
      before treatment), one month (after one month of treatment defined at baseline), and 2 months
      (after one month of treatment crossover).

      During the study period, the patients were followed by trained professionals and received all
      the necessary information about the use of each treatment. After three days of treatment,
      patients were contacted by phone to ensure the adherence treatment and to solve potential
      doubts. After each week of treatment, patients returned to the sleep clinic to management of
      the adherence data from the memory card (CPAP group) and data from the full filled sleep log
      (Placebo group), and also to had reinforced the information about the study protocol. Any
      issues or concerns about the treatment were also solved by phone calls.

      All patients were photographed in the three experimental times: baseline (immediately before
      treatment), one month (after one month of treatment defined at baseline) and 2 months (after
      one month of treatment crossover). Photographs were taken by a trained photographer in a
      standardized manner. The photographer was blind to the experimental condition of patients.
      The photographs were displayed in a randomized order for 704 observers (general population,
      both genders, similar socioeconomic status and education), who were unaware of the conditions
      of the study. The observers rated the faces for attractiveness (very unattractive to very
      attractive), health (very sick to very healthy), and tiredness (not at all tired to very
      tired). Perceived age was also rated by the observers' evaluation by the Qualtrics Survey
      Software.

      The high-resolution analyzing system VISIA TM (Canfield Scientific Inc. Fairfield USA) was
      used for computer analysis to precisely measure presence of porphyrins (P. acnes),
      coloration/evenness, vascular features, porosity, wrinkles and skin texture of the patient's
      face. The photographs from VISIA TM were taken after standard skin preparation and were
      analyzed by a specific analysis algorithm. Collection of dermatological assessments was
      conducted in three experimental sampling times.

      During treatment period, the patients 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. After
      CPAP treatment, compared to baseline and after placebo treatment, improvement in the
      objective sleep quality, sleepiness, quality of life and depressive symptoms were observed (P
      <0.05). 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. Linear
      regression analysis identified the number of days with CPAP treatment, total sleep time and
      percentage of total sleep time with oxyhemoglobin saturation below 90% were predictors of
      decreasing of rated age after CPAP treatment.

      In conclusion, sleepy patients with severe OSA had a younger appearance after one month of
      CPAP treatment.
    

Intervention name(s): continuous positive airway pressure; Breathe Right ®
Intervention type(s): Device; Other
Intervention description(s): device to treat obstructive sleep apnea using positive airway pressure with a nasal mask; Nasal dilator strip treatment used during sleep to open the nasal airway
Other intervention name(s): Philips Respironics, System One, REMstar Pro; GlaxoSmithKline Brasil Ltda.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obstructive sleep apnea; treatment; placebo; appearance; skin quality