Effects of Myofunctional Therapy With an Application in Severe Apnea/Hypopnea Sleep Obstructive Syndrome (MTASSAOS)
Condition: Obstructive Sleep Apnea-hypopnea Syndrome
MeSH terms: Apnea; Sleep Apnea, Obstructive; Syndrome
Study type: Interventional

Summary: 
      • Background and study aims: Obstructive sleep apnea is a potentially serious sleep disorder.
      It causes breathing to stop and start repeatedly during sleep. There are several types of
      sleep apnea, the most common of which is obstructive sleep apnea. This type of apnea occurs
      when an individual's throat muscles intermittently relax and block the airway during sleep.

      The classic treatment for this disease is based on weight loss, and exercise, and the use of
      a continuous positive airway pressure (CPAP) machine.

      Myofunctional therapy (MT) is one of the newest treatments for sleep-disordered breathing. MT
      is based on daily exercises of the throat muscles in an attempt to strengthen them and
      facilitate opening of the airway.

      Who can participate? Patients diagnosed with severe sleep apnea and aged between 18-75 years.

      What does the study involve? Participants will be randomly allocated to either use of the
      "AirwayGym" smartphone app or no treatment for 3 months. The AirwayGym app provides
      instructions on how to perform exercises to strengthen the throat muscles and reminds
      participants to perform the exercises for 20 min per day. Participants will be assessed
      monthly at the clinic.

      What are the possible benefits and risks of participating? Benefits: Curing sleep apnea
      syndrome. There are no significant risks for participants.

      Where is the study run from? Hospital Quirónsalud Marbella (Spain) When is the study starting
      and how long is it expected to run for? October 2018 to January 2021 Who is funding the
      study? Investigator initiated and funded Who is the main contact? Dr. Carlos O'Connor Reina,
      coconnor@us.es
    

Detailed description: 
      INTRODUCTION Obstructive sleep apnea/hypopnea syndrome (OSAHS) has become one of the more
      serious health problems worldwide (Mendes et al., 2014). Because of its relationship with
      obesity, its prevalence and incidence have increased. It is associated with morbidities such
      as cardiovascular and cerebrovascular diseases. The classic treatment of this disease is
      based on dietary measures, weight loss, and exercise, and the use of a continuous positive
      airway pressure (CPAP) machine.

      Myofunctional therapy (MT) is one of the newest treatments for sleep-disordered breathing
      (Camacho et al., 2015). MT is based on daily exercises using the oropharyngeal muscles in an
      attempt to strength them and facilitate opening of the airway. OSAHS originates from the
      suboptimal function of the dilator muscles of the airway. Therefore, MT is a therapy designed
      theoretically to deal with the underlying mechanism of this disease (Korhan et al., 2015). MT
      is based on oropharyngeal exercises described by diagrams, videos, and weekly instructions
      from a myofunctional therapist. The patient is instructed to perform the exercises regularly,
      for at least 3 months, and for 30 min daily. In some cases, patients perform exercises by
      themselves at home without substantial feedback and without giving precise information to the
      therapist about their performance of the exercises (O'Connor et al., 2019).

      Most existing mobile health (mHealth) apps for OSAHS focus on diagnosis of snoring or OSAHS
      (Isetta et al., 2017), while a few are designed to promote adherence to treatment with CPAP
      (Camacho et al., 2015). To our knowledge, there are no apps that focus on the treatment of
      OSAHS. However, mobile technology could be especially valuable in treating OSAHS patients
      because of its potential to promote patient empowerment and self-management (Iftikhar et al.,
      2017).

      One of the best treatments for OSAHS is exercise and weight loss (Iftikhar et al., 2018).
      Because patients' time is limited, the investigators consider that there will be a greater
      probability of their performing the exercises if they are able to do wherever and whatever.
      Therefore, the investigators designed and developed a novel mHealth app to promote
      oropharyngeal exercises while interacting with a smartphone. In this prospective randomized
      multicenter clinical trial, the investigators aim to evaluate adherence to the app and its
      effectiveness in a group of patients (AirwayGym group, AGG) with severe OSAHS compared with a
      control group (CG) of similar patients.

      HYPOTHESIS The regular use of the AirwayGym app, which is designed to perform and increase
      adherence to MT, will improve OSAHS in patients with severe disease ,apnea hypopnea index
      (AHI)>30) by increasing the tone of their upper airway muscles.

      OBJECTIVES The main objective will be to study the evolution of the use of the app based on
      MT in patients diagnosed with severe OSAHS.

      Secondary Objectives:

        1. To evaluate the influence of MT using an app on the change in the AHI in patients
           diagnosed with severe OSAHS.

        2. To evaluate O2 nadir and O2 desaturation index.

        3. To use scores obtained using the Iowa Oral Performance Instrument (IOPI) to evaluate the
           tone of genioglossus and buccinator muscles.

        4. To evaluate subjective morning somnolence and sleep quality score using the Epworth
           Sleepiness Scale and Pittsburgh Sleep Quality Index.

      METHODS Design: Prospective controlled quasi-experimental clinical trial in patients with
      severe OSAHS (AHI>30). Study population: Patients recently diagnosed with severe OSAHS who
      agree to participate in this clinical trial.

      Evaluation of the effectiveness of use of the app in performing MT in patients with severe
      OSAHS will be performed using the longitudinal values obtained during study, based on the
      percentage of improvement in the AHI observed during follow-up. This percentage has been
      calculated from results reported in previous MT studies published and presented in the
      bibliography. To achieve a confidence level of 95% and power of 80% with an estimated
      improvement of the AHI of 60%, the required sample size is 30 patients (15 AirwayGym group
      [AGG], 15 CG).

      Randomization will be based on the consecutive order of patient enrollment, with odd numbers
      allocated to the AGG (patients treated with the app) and even numbers to the CG (patients
      without complementary therapy).

      Patients without a smartphone will be directly recruited to the CG. VARIABLES EVALUATED: Age,
      sex, weight, height, body mass index (BMI), waist circumference (belly button height), neck
      circumference, IOPI lingual and buccinator, AHI, O2 desaturation index, and O2 nadir.

      Questionnaires: Friedman stage, Epworth Sleepiness Scale, and Pittsburgh Sleep Quality Index
      PROCEDURE The AGG will use the app, which was created in a collaboration between the Sleep
      Units of Hospital Quirónsalud Marbella and Campo de Gibraltar. The novelty of this app is
      that it is the first in the healthcare market in which the patient can interact directly with
      the smartphone; the phone provides acoustic feedback about the efficacy of the exercises
      performed and is focused on sleep apnea disease and improving proprioceptive deficits. The
      app includes nine exercises based on MT that attempt to enhance the tonicity of the various
      muscles involved in the pathogenesis of OSAHS. Before every exercise, an animated
      demonstration and a video show the patient how to perform the exercise. At the conclusion of
      each exercise, the patient receives feedback about the success of their performance via a
      point score. When the patient finishes the exercises, they are saved in the cloud and a
      therapist can evaluate the performance of them. A chat function is available where patient
      can contact the therapist.

      This app complies with regulation 2002/58/Community European (CE) and (UE) 2016/679
      concerning data protection.

      The main objective of these exercises is to increase the tone of the extrinsic muscles of the
      tongue.

      The exercises are based on those described elsewhere (Guimaraes et al., 2009), adapted to
      obtain feedback with the phone and to stimulate proprioceptive sensors with acoustic
      feedback.

      For hygiene reasons, it is recommended that participants cover the screen with cling film
      during all exercises.

      The CG does not use any therapy for OSAHS for 3 months. All patients will attend hospital
      once a month for measurement of the variables (weight, height, BMI, neck and waist
      circumference, completion of the questionnaires, IOPI scores)

      Schedule of visits:

      SELECTION VISIT Patients with newly diagnosed severe OSAHS based on home or laboratory
      polygraphy with measures of AHI, O2 saturation, and O2 nadir were evaluated. All sleep
      studies were manually interpreted by a sleep technician according to the standard criteria of
      the American Academy of Sleep Medicine (AASM) Manual for the Scoring of Sleep and Associated
      Events, and were reviewed by certified physicians. Information about inclusion and exclusion
      criteria, evaluation of the type of smartphone used, previous experience with the app, and
      the study protocol was provided. After any questions were resolved, the patient agreed to
      participate and signed informed consent (IC).

      INITIAL VISIT Participants were evaluated by an Ear nose and throat (ENT) specialist and
      underwent pharyngoscopy, rhinofibrolaryngoscopy, Friedman staging, Marchesani protocol, and
      examination of their temporomandibular joint dysfunction. If the patient presented with
      tonsillitis grade IV, complete nose obstruction, ankyloglossia, or problems with
      temporomandibular joint dysfunction, they were excluded from the study.

      SECOND VISIT: Variables were measured (weight, height, BMI, neck and waist circumference,
      completion of questionnaires, IOPI scores) and randomization was performed to AGG or CG.
      Participants in the AGG were instructed about the use of the app and the exercises to do.

      FOLLOW-UP VISITS:

      AGG: Participants performed exercises daily for about 20 min. Follow-up visits occurred after
      1 month (visit 3) and 3 months (visit 4). At these visits, variables were measured,
      questionnaires completed, and exercise performance checked.

      CG: Follow-up visits occurred after 1 month (visit 3) and 3 months (visit 4). At these
      visits, variables were measured, questionnaires completed, and it was checked that no other
      therapies are being followed.

      Final visit: At 3 months for both groups. At this visit, questionnaires were completed,
      variables were measured again, and laboratory or in-home polygraphy was performed. The total
      study duration for each participant was 3 months.

      DISCONTINUATION CRITERIA

      A participant in either group was excluded from the study if:

        1. They did not perform exercises during at least 85% of the scheduled sessions,or were
           lost to follow-up because they did not attend hospital visits.

        2. They lost 5% of their body weight during study participation. Data were collected in a
           database. Nominal variables were described by their frequency distribution. Quantitative
           variables were assessed by calculating the arithmetic mean and standard deviation.
           Baseline characteristics of the two groups of participants with OSAHS were compared by
           two-tailed paired t tests for continuous variables and chi-squared or Fisher's exact
           test for nominal variables. For variables with skewed distribution, the investigators
           performed Mann-Whitney tests. In addition, the investigators performed Pearson
           correlation analysis of changes in AHI compared with changes in possible explanatory
           variables, including BMI and neck and waist circumference. A P value less than 0.05 was
           considered significant.

      The main outcome measures are polygraphy findings at the beginning and end of the study, IOPI
      scores at the beginning and end of the study, Epworth Sleepiness Scale and Pittsburgh Sleep
      Quality Index at all visits, weight in kg, height in cm, BMI in kg/m2, and neck and waist
      circumference in cm at all visits.

      ETHICAL APPROVAL After evaluating and revising the protocol, the Investigation Ethical
      Committee (EC) from Costa del Sol approved the study with the code AWGAPN-2019-01. Before
      starting the trial, all participants had to have signed and dated all IC approved by the EC.

      Access to data and data protection. To ensure confidentiality of study data, the original
      data were stored in the Hospital and only the investigators and the Investigation EC had
      access.

      UTILITY This app could improve participants' AHI and quality of life and reduce their
      clinical symptoms and need for treatment.
    

Intervention name(s): The intervention consists of myofunctional therapy (MT) using the AirwayGym app.
Intervention type(s): Device
Intervention description(s): Intervention. Patient newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the App AirwayGym 20 minutes a day during 90 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Interventional prospective multicentre trial with consecutive random assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: SEVERE OSAHS; MYOFUNTIONAL THERAPY; M HEALTH APPLICATION; TELEMEDICINE