The Inspiratory Muscle Training Improves the Severity of Obstructive Sleep Apnea and Sleep Quality?
Condition: Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Introduction: Obstructive sleep apnea (OSA) is characterized as a disorder that causes
      recurrent episodes of partial or complete obstruction of the upper airways during sleep.
      Objectives: In this way, the study will investigate the efficacy of inspiratory muscle
      training in improving the severity of obstructive sleep apnea and sleep quality of the
      research participants. Methods: The investigators will invite individuals of both sexes
      diagnosed with obstructive sleep apnea moderate and / or severe, arising from the Sleep
      Laboratory of the Hospital PROCAPE, located in Recife. This is a randomized-controlled trial,
      double-blind to be held in two groups: A) Individuals with OSA (moderate or severe) -
      Experimental Group: The components of this group hold the IMT with load of 75% of Pimáx. (
      assessed weekly) for eight weeks. B) Individuals with OSA (moderate or severe) -Group
      control: This group will simulate training, performing no-load training for the same period
      the intervention group. All guidance on training and weekly evaluations will be made by the
      responsible for the research physiotherapist in Cardiopulmonary Physiotherapy Laboratory
      (LACAP - UFPE). Before and after the eight weeks, the groups will be evaluated by
      polysomnography, acoustic pharyngometry, tests for respiratory muscle strength
      (Manovacuometry) and lung function (spirometry). Expected results: Improvement of severity of
      OSA and sleep quality of research subjects after the completion of eight weeks of TMI when
      compared to the control group.
    

Detailed description: 
      Initially, the medical records of patients already submitted to PSG will be analyzed. Those
      classified as having moderate (15>AHI<30events/h) and severe (AHI>30events/h) OSA will be
      contacted by telephone to explain the procedure for participating in the research.
      Individuals who accept to participate in the study will be invited to attend the
      Cardiopulmonary Physiotherapy Laboratory and will perform an assessment consisting of
      collecting personal information through the application of a form, filling in the IPAQ and
      collecting anthropometric and vital signs data.

      All members will be submitted to a polysomnography exam before and after the 8 weeks of
      training, in order to detect if there was a change in the AHI due to the training. The
      examination must be performed by the same physician responsible for interpreting the results
      and the diagnostic opinion, be conducted throughout the night, in spontaneous sleep, without
      any sedation or sleep deprivation. A computerized polysomnography system will be used to
      perform the exam. The parameters measured will be electrocardiogram (ECG), blood pressure
      (BP), chest and abdominal movements (plethysmography), peripheral oxygen saturation (SpO2)
      (pulse oximetry), nasal/buccal airflow (thermistors), body position and snoring ( MIC). In
      addition, the number of apneas, hypopneas, AHI and SpO2 levels will be calculated. The
      monitoring of pleasure or displeasure during the IMT session will be performed by applying
      the affective valence scale (AV), proposed by Hardy and Rejeski (1989). The scale is
      quantified from +5 to -5, corresponding, respectively, to the two antagonistic descriptors of
      the feeling during physical activity: "very good" and "very bad". In addition to these, the
      VA scale has intermediate descriptors: +3 = good; +1 = reasonably good; 0 = neutral; -1 =
      reasonably bad; -3 = bad. The scale will be answered by the volunteers at each weekly session
      performed with the physical therapist Subjects will complete the ESE before and after the 8
      weeks of TMI. It is a scale containing eight daily situations requesting a self-assessment of
      the individual about the chance of dozing in the execution of these activities, scoring from
      0 to 3, where 0: no chance of dozing, 1: small chance, 2: moderate chance, 3: high chance
      (ANNEX 2) (BERTOLAZI, ALESSANDRA NAIMAIER et al., 2009).

      Subjects will complete the PSQI before and after the 8 weeks of TMI. It consists of a
      self-assessment questionnaire, which investigates sleep quality and disturbances over a
      period of 1 month. It consists of nineteen individual items that give rise to seven scoring
      "components": subjective sleep quality, sleep latency, sleep duration, habitual sleep
      efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The sum of
      the scores obtained in the seven components generate a global score (BERTOLAZI, ALESSANDRA
      NAMAIER; BARRETO, 2008). Subjects will complete the SF-36 before and after the 8 weeks of
      IMT. It consists of a generic instrument for assessing quality of life, easy to administer
      and understand, but not as extensive as the previous ones. It is a multidimensional
      questionnaire formed by 36 items, encompassed in 8 scales or components: functional capacity,
      physical aspects, pain, general health status, vitality, social aspects, emotional aspects,
      and mental health. It presents a final score from 0 to 100, in which 0 corresponds to the
      worst general health status and 100 to the best health status (ANNEX 4) (CICONELLI, 1999).

      Subjects will complete the IPAQ prior to the TMI in order to assess their level of physical
      activity and ensure that only subjects classified as sedentary or insufficiently active are
      participating in the study. It is a questionnaire that makes it possible to estimate the time
      spent during the week with physical activities with moderate and strong intensity, in
      different contexts of daily life, such as: transport, work, performing household chores and
      leisure, as well as the time spent in passive activities, performed in the sitting position.
      The short version of the IPAQ contains seven open questions and its information allows
      estimating the time spent weekly in different spectra of physical activity (walking and
      physical efforts with moderate and strong intensities) and not performing physical activity
      (sitting position) (BERTOLDO BENEDETTI et al., 2007; MATSUDO et al., 2012). Subjects will
      perform manovacuometry before and weekly until completing 8 weeks of IMT. The present study
      will follow the recommendations proposed by the Thoracic Society/European Respiratory Society
      (ATS/ERS) and the Brazilian Society of Pneumology and Tisiology (SBPC), thus, during the
      collection of values referring to MIP and MEP, the patient will be seated, with the free arms
      and will be guided by the person responsible for carrying out the test to attach a mouthpiece
      (divers type) with a leak hole of 2mm of internal diameter to their mouth, the individual
      will be instructed to maintain an inspiratory and expiratory pressure for at least 1.5s in
      order to observe the maximum sustained pressure for one second (maximum mean pressure) in the
      manovacuometer (MVD 300, Globalmed, Brazil), used in the Cardiopulmonary Laboratory of the
      Department of Physiotherapy of the Federal University of Pernambuco (NEDER et al., 1999; ATS
      /ERS, 2002).

      The test will be performed by an experienced operator who verbally encourages the subject to
      perform a maximal inspiratory effort against an occluded airway (Mueller maneuver) and a
      maximal expiratory effort against an occluded airway (Valsalva maneuver) at or near the
      residual volume ( RV) and total lung capacity (TLC respectively). The patient will be
      encouraged to perform the maneuvers to prevent air from escaping around the mouth, and will
      be instructed to hold the cheeks, if necessary, with the hands during the expiratory effort,
      as well as to press the lips firmly on the mouthpiece.

      The three tests will be used (regardless of the order), which meet all the criteria
      considered acceptable. The measures with the highest value presented will be used (with
      variation less than or equal to 10% among the others). When the MIP values are identical, the
      one with the highest PPpeak value will be recorded, and successively the highest PPlatô and
      the lowest VPlatô

      Some pulmonary function items will be evaluated before and weekly until completing the 8
      weeks of IMT, described below:

        -  Slow vital capacity (SVC): it is measured during the expiration phase from the total
           lung capacity (TLC) or during inspiration from the residual volume (RV).

        -  Forced Vital Capacity (FVC): the patient will be asked to exhale as quickly and
           intensely as possible in a volume or flow spirometer after inhaling to full lung
           capacity. The exhaled volume can be read through the volume-time plot produced on a
           graph or derived from the flow integration. • Forced expiratory volume in one second
           (FEV1):

        -  Subsequently, the FEV1/VC and FEV1/FVC ratios will be calculated. The Berlin
           Questionnaire is considered as one of the most used tools to assist in OSA screening.
           The Berlin questionnaire in April 1996 and validated by Netzer et al in 1999. It is
           composed of self-administered questions, divided into three categories. Category 1
           refers to the presence of snoring, category 2 assesses daytime sleepiness and falling
           asleep during daily activities, and category 3 looks at the history of Systemic Arterial
           Hypertension (SAH) and calculates the Body Mass Index (BMI) ( NETZER; STOOHS; NETZER, et
           al., 1999) After the initial assessment, patients will follow an intervention protocol
           for eight weeks using powerbreathe® (classic Light Resistance), a device capable of
           providing linear resistance in the inspiratory phase. . In the learning session (1st
           contact), the variables heart rate (HR), systolic blood pressure (SBP) and diastolic
           blood pressure (DBP) will be monitored in order to provide greater safety during
           exercise and the physical therapist will guide how to perform of the exercise and the
           other sessions will be carried out by the individual at his/her home.

      Subjects in both groups (intervention and placebo) will perform the training seated, using a
      nose clip, performing three cycles of thirty incursions, twice a day, seven days a week. For
      the intervention group set at 40% of MIP. and load ≤10% of MIP will be maintained. for
      individuals in the placebo group (value considered lower than the baseline level so that
      there is, in fact, training).

      Another evaluator will adjust the load intensity weekly by evaluating MIP throughout the
      intervention protocol stage, so that blinding is preserved (CHARUSUSIN et al., 2013).

      After the randomization process is carried out using the random allocation software, the
      individuals will receive a training diary from the researcher, to record the time of the
      exercises, the possible discomforts or difficulties of realization that may happen and for
      there to be a control of the execution of the training.

      Each patient will receive a device (powerbreathe®) to carry out the training and the
      necessary guidelines for the training to take place at home. The necessary adjustments for
      the applied load will be made by the researcher through weekly meetings, respecting the
      individual needs of each patient, which will be determined by the advancement or not of the
      effort tolerance.

      The first phase of the research will begin after the signing of the Free and Informed Consent
      Term (ICF), the physical evaluation and submission to the other tests, where each patient
      will be evaluated and guided to perform the proposed exercises that will be determined
      according to the ability of each individual.

      The two groups will perform the training twice a day, however, the individuals in the control
      group will only use load <10% of their PI max and the intervention group will be subjected to
      a load of 40% of their PI max value.
    

Intervention name(s): Inspiratory Muscle Training; Inspiratory Muscle Training Sham
Intervention type(s): Other; Other
Other intervention name(s): Obstructive Sleep Apnea; Respiratory Muscle Training; Powerbreath; No treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment