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Obstructive Sleep ApneaNCT02117271

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

A study testing continuous positive airway pressure and Breathe Right ® in people with Obstructive Sleep Apnea, run by Nucleo Interdisciplinar da Ciencia do Sono at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 60 years
Conditions the study is for
Obstructive Sleep Apnea
What is being tested?
continuous positive airway pressure and Breathe Right ®
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteBrazil
Study dates
Mar 2014to Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Nucleo Interdisciplinar Da Ciencia Do Sono

    São Paulo, São Paulo, 05401-000

Other trials in Brazil

About this study

Official title: "BEAUTY CPAP": The Impact of the Treatment of Obstructive Sleep Apnea With Continuous Positive Airway Pressure on Appearance and Age: a Randomized Crossover Placebo-controlled Study

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.

Read more

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.

Read the 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.

Being tested
continuous positive airway pressure, Breathe Right ®
Keywords
obstructive sleep apnea, treatment, placebo, appearance, skin quality
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • continuous positive airway pressureDevice

    Also called Philips Respironics, System One, REMstar Pro

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

  • Breathe Right ®Other

    Also called GlaxoSmithKline Brasil Ltda.

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

Study groups in NCT02117271
Study groupRoleWhat they receive
nasal dilator stripPlacebo comparatorBreathe Right ® nasal dilator strip used during sleep
Receives: Other: Breathe Right ®
continuous positive airway pressureExperimentalnasal continuous positive airway pressure used during sleep
Receives: Device: continuous positive airway pressure

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 month

Secondary outcomes (1)
  1. skin quality

    Computer analysis of face image to measure presence of porphyrins (P. acnes), coloration/evenness, vascular features, porosity, wrinkles and skin texture.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionMar 2017
  4. Study completionMar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02117271
Sponsor's protocol ID
0068
Status last verified
Mar 2017
First submitted
10 Apr 2014
Last updated
29 Mar 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 30926396

Questions about this trial

What is this clinical trial studying?

A study testing continuous positive airway pressure and Breathe Right ® in people with Obstructive Sleep Apnea, run by Nucleo Interdisciplinar da Ciencia do Sono at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

appearance (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02117271, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.

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