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

NCT02963844 | Completed DMC

• 1 other identifier: 08079697450
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

• Polysomnography - Apnea Hypopnea Index

  number of apneas and hypopneas

  8 weeks

Secondary Outcomes (1)

• Sleep quality index of Pittsburgh - Sleep Quality

  8 weeks

Study Arms (2)

Inspiratory Muscle Training

EXPERIMENTAL

The components of this group held the IMT load equivalent to 75% of the Pimáx. (measured weekly) for eight weeks.

Other: Inspiratory Muscle Training

Inspiratory Muscle Training Sham

SHAM COMPARATOR

This group simulate the training, conducted the training without charge for the same period the intervention group.

Other: Inspiratory Muscle Training Sham

Interventions

Inspiratory Muscle Training OTHER

Also known as: Obstructive Sleep Apnea, Respiratory Muscle Training, Powerbreath

Inspiratory Muscle Training

Inspiratory Muscle Training Sham OTHER

Also known as: No treatment

Inspiratory Muscle Training Sham

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Universidade Federal de Pernambuco

Recife, Per, Brazil

Location

Related Publications (7)

• Sengul YS, Ozalevli S, Oztura I, Itil O, Baklan B. The effect of exercise on obstructive sleep apnea: a randomized and controlled trial. Sleep Breath. 2011 Jan;15(1):49-56. doi: 10.1007/s11325-009-0311-1. Epub 2009 Nov 7.

  PMID: 19898884 BACKGROUND

• Kline CE, Crowley EP, Ewing GB, Burch JB, Blair SN, Durstine JL, Davis JM, Youngstedt SD. The effect of exercise training on obstructive sleep apnea and sleep quality: a randomized controlled trial. Sleep. 2011 Dec 1;34(12):1631-40. doi: 10.5665/sleep.1422.

  PMID: 22131599 BACKGROUND

• Charususin N, Gosselink R, Decramer M, McConnell A, Saey D, Maltais F, Derom E, Vermeersch S, van Helvoort H, Heijdra Y, Klaassen M, Glockl R, Kenn K, Langer D. Inspiratory muscle training protocol for patients with chronic obstructive pulmonary disease (IMTCO study): a multicentre randomised controlled trial. BMJ Open. 2013 Aug 5;3(8):e003101. doi: 10.1136/bmjopen-2013-003101.

  PMID: 23921069 BACKGROUND

• Carneiro G, Florio RT, Zanella MT, Pradella-Hallinan M, Ribeiro-Filho FF, Tufik S, Togeiro SM. Is mandatory screening for obstructive sleep apnea with polysomnography in all severely obese patients indicated? Sleep Breath. 2012 Mar;16(1):163-8. doi: 10.1007/s11325-010-0468-7. Epub 2011 May 29.

  PMID: 21626286 BACKGROUND

• Bertolazi AN, Fagondes SC, Hoff LS, Pedro VD, Menna Barreto SS, Johns MW. Portuguese-language version of the Epworth sleepiness scale: validation for use in Brazil. J Bras Pneumol. 2009 Sep;35(9):877-83. doi: 10.1590/s1806-37132009000900009. English, Portuguese.

  PMID: 19820814 BACKGROUND

• Chien MY, Wu YT, Lee PL, Chang YJ, Yang PC. Inspiratory muscle dysfunction in patients with severe obstructive sleep apnoea. Eur Respir J. 2010 Feb;35(2):373-80. doi: 10.1183/09031936.00190208. Epub 2009 Jul 30.

  PMID: 19643936 BACKGROUND

• Vranish JR, Bailey EF. Inspiratory Muscle Training Improves Sleep and Mitigates Cardiovascular Dysfunction in Obstructive Sleep Apnea. Sleep. 2016 Jun 1;39(6):1179-85. doi: 10.5665/sleep.5826.

  PMID: 27091540 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• JOSE CARLOS NN JUNIOR, M.D.

  Universidade Federal de Pernambuco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2016
• First Posted: November 15, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)