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Clinical Trials/NCT02963844
NCT02963844CompletedNot Applicable

The Inspiratory Muscle Training Improves the Severity of Obstructive Sleep Apnea and Sleep Quality?

Universidade Federal de Pernambuco1 site in 1 country16 target enrollmentStarted: November 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
16
Locations
1
Primary Endpoint
Polysomnography - Apnea Hypopnea Index

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
30 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Individuals diagnosed with OSA (moderate or severe) by polysomnography;
  • Be aged between 30 and 65;
  • Sedentary or insufficiently active according to the International Physical Activity Questionnaire (IPAQ);
  • Who are able to complete the proposed protocol;
  • Individuals with BMI ≥ 18 ≤ 39.9 kg / m2.

Exclusion Criteria

  • Patients in non-invasive ventilation use (NIV);
  • Individuals with account of orthopedic problems, neurological or cardiovascular or respiratory disease in your medical history that may cause obstruction during the stages of the research;
  • Patients with BMI> 40 kg / m2.

Outcomes

Primary Outcomes

Polysomnography - Apnea Hypopnea Index

Time Frame: 8 weeks

number of apneas and hypopneas

Secondary Outcomes

  • Sleep quality index of Pittsburgh - Sleep Quality(8 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

José Carlos Nogueira Nóbrega Júnior

Principal Investigator

Universidade Federal de Pernambuco

Study Sites (1)

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