Oropharyngeal Exercises and Inspiratory Muscle Training in Obstructive Sleep Apnea

NCT04201236 | Completed

• 1 other identifier: 2019/11
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The effects of orofarangeal exercises (OE) and inspiratory muscle training (IMT) on sleep quality, disease severity, and airway muscle tone have been investigated in several studies. IMT and OE exercise modalities for patients and practitioners have advantages and disadvantages. It is recommended to compare exercise modalities in the studies. Whether OE or IMT exercise type is more effective on disease severity, sleep quality and snoring has not been investigated. The aim of this study was to compare the effectiveness of inspiratory muscle training and oropharyngeal exercises in patients with OSAS in terms of disease severity, snoring, daytime sleepiness, respiratory muscle strength and sleep quality.

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apnea; oropharyngeal exercises; inspiratory muscle training; sleep quality

Outcome Measures

Primary Outcomes (1)

• Polysomnography

  Sleep efficiency, apnea-hypopnea index (AHI). Higher sleep efficiency and lower AHI values shows that patient have better status and lower disease severity

  2 day

Secondary Outcomes (7)

• Maximal inspiratory and expiratory muscle strength measurement with mouth pressure device

  6 day

• 6 minute walk test

  2 day

• Epworth Sleepiness Scale

  2 day

• Berlin Questionnaire

  2 day

• Functional Outcomes of Sleep Questionnaire

  2 day

Study Arms (3)

Oropharyngeal exercises

EXPERIMENTAL

Oropharyngeal exercises include soft palate, tongue and facial muscle exercises as well as stomatognathic function exercises. Training sessions were held once a day, 5 days a week for 12 weeks under the supervision of a mirror.

Other: oropharyngeal muscles strengthening exercise

Inspiratory muscle training

EXPERIMENTAL

The inspiratory muscle training group was administered for 12 weeks starting from 30% of maximal oral pressure, 7 days a week, 15 minutes twice a day. Patients came to the control once a week, mouth pressures were measured and training pressure was adjusted in 30% of the new value.

Other: respiratory muscle strengthening exercise

Control

NO INTERVENTION

This group was only monitorized without any rehabilitation intervention.

Interventions

respiratory muscle strengthening exercise OTHER

These exercises strengthen locally inspiratory muscles. IMT can be done with threshold loaded devices.

Inspiratory muscle training

oropharyngeal muscles strengthening exercise OTHER

These exercises strengthen locally oropharyngeal muscles. Oropharyngeal exercise can be done with some facial movements .

Oropharyngeal exercises

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \*To be diagnosed with mild, moderate and severe OSAS.

You may not qualify if:

• Patients with a history of stroke,
• neurological disease,
• severe obstructive nasal disease,
• and infection in the last month,
• BMI being 40 kg /m2 or more.

Sponsors & Collaborators

• Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital: lead

Study Sites (1)

Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital

Trabzon, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Adem Celik, MD

  Ahi Evren Thoracic and Cardiovascular Surgery Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 17, 2019
• Study Start: April 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: December 18, 2019

Record last verified: 2019-12

Locations

TU (1)