Inspiratory Muscle Training on Obstructive Sleep Apnea Syndrome

NCT04457583 | Completed

• 1 other identifier: CAAE49197915.3.0000.5256
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Studies have shown the influence of exercise on sleep architecture and efficiency, although its protocols, procedures, effects and mechanisms of action have not been clearly explained and documented in the treatment of obstructive sleep apnea hypopnea syndrome (OSAHS), which is thought to be the main sleep disorder due to its high prevalence and clinical, social and cognitive consequences. Objective: To evaluate the effect of inspiratory muscle training (IMT) in OSAHS, by analyzing their influence on the quality of sleep, inspiratory muscle strength and polysomnography parameters. Patients and Methods: Controlled and randomized clinical trial involving 75 patients with OSAHS diagnosed by polysomnography. Measurements of maximal inspiratory pressure (MIP) will be performed. Pittsburgh scale Epworth, Sleepiness Scale, Short Form-36, and Berlin / Stanford questionnaires will be used for assessment of sleep quality, daytime sleepiness, health related quality of life quality of health, and the evaluation of snoring. Patients of the intervention group will undergo IMT with an initial load of 40% of MIP. The intervention will be performed daily for 12 weeks employing the exercise inspiratory device (POWERbreathe, HaB Ltd, UK). The main end point will be the effect of the training program on the index of apnea/hypopnea (IAH) assessed by polysomnography. Secondary end points will include effects of the training program on: the quality of sleep, inspiratory muscle strength, the health related QOL. Expected Results: if the hypothesis is confirmed, there will be improvements on the apnea / hypopnea index, on the quality of sleep and on the health related QOL.

Conditions

Inspiratory Muscle Training; Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea; Inspiratory Muscle Training; Life of quality

Outcome Measures

Primary Outcomes (1)

• Apnea hypopnea index

  measured by polysomnography

  up to 04 weeks

Secondary Outcomes (4)

• Sleep quality: Pittsburgh sleep quality index

  up to 04 weeks

• Quality of life assessed by the The Medical Outcomes Study - Short-form 36 (SF-36)

  up to 04 weeks

• Inspiratory muscle strength

  up to 04 weeks

• Daytime sleepiness

  up to 04 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Procedure: Inspiratory muscle training with powerbreathe with a linear pressure resistance using an inspiratory load of 40% of maximal inspiratory pressure (adjusted weekly), seven days a week, 30 exercises daily for 12 weeks.

Device: Inspiratory muscle training with powerbreathe

Control

NO INTERVENTION

Procedure: Training with the same equipment but without load-generating resistance.

Interventions

Inspiratory muscle training with powerbreathe DEVICE

Participants will be submitted to a linear pressure resistance (Powerbreathe) with an inspiratory load of 40% of maximal inspiratory pressure (adjusted weekly), seven days a week, session duration of 30 exercises for 12 weeks.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age equal or greater than 18 years.
• Diagnosis of obstructive sleep apnea and hypopnea syndrome (AHI\> 5 events / hour).

You may not qualify if:

• Acute or chronic pulmonary disease, uncontrolled arterial hypertension, heart failure, chronic renal failure and neurological disease.
• Drug therapy that can influence muscle strength.
• Psychiatric illness that may make adherence to the research protocol difficult.
• Speech therapy or respiratory therapy in the last 3 months.
• Orthodontic therapy with intraoral device.
• BMI\> 40 kg / m².

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Hospital Naval Marcilio Dias

Rio de Janeiro, Rio de Janeiro, 20725-090, Brazil

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Jocemir R Lugon, MD, PhD

  Universidade Federal Fluminense

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Controlled and randomized clinical trial involving 70 patients with OSAHS diagnosed by polysomnography. Measurements of maximal inspiratory pressure (MIP) will be performed. Pittsburgh scale Epworth, Sleepiness Scale, Short Form-36, and Berlin / Stanford questionnaires will be used for assessment of sleep quality, daytime sleepiness, health related quality of life quality of health (QOL), and the evaluation of snoring. Patients of the intervention group will undergo IMT with an initial load of 40% of MIP. The intervention will be performed daily for 12 weeks employing the exercise inspiratory device (POWERbreathe, HaB Ltd, UK). The main end point will be the effect of the training program on the index of apnea / hypopnea (IAH) assessed by polysomnography. Secondary end points will include effects of the training program on: the quality of sleep, inspiratory muscle strength, the health related QOL

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: July 7, 2020
• Study Start: December 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: July 7, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)