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Oropharyngeal Exercises and Inspiratory Muscle Training in Obstructive Sleep Apnea

NCT ID: NCT04201236

Last Updated: 2019-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2019-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructive Sleep Apnea

Keywords

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obstructive sleep apnea oropharyngeal exercises inspiratory muscle training sleep quality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oropharyngeal exercises

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.

Group Type EXPERIMENTAL

oropharyngeal muscles strengthening exercise

Intervention Type OTHER

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

Inspiratory muscle training

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.

Group Type EXPERIMENTAL

respiratory muscle strengthening exercise

Intervention Type OTHER

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

Control

This group was only monitorized without any rehabilitation intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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respiratory muscle strengthening exercise

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

Intervention Type OTHER

oropharyngeal muscles strengthening exercise

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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NUREL ERTURK

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adem Celik, MD

Role: STUDY_CHAIR

Ahi Evren Thoracic and Cardiovascular Surgery Hospital

Locations

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Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital

Trabzon, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2019/11

Identifier Type: -

Identifier Source: org_study_id