NCT04454242

Brief Summary

The effect of expiratory muscle strength training (EMST) on sleep quality, disease severity, and respiratory muscle strength has been previously investigated in OSA syndrom. Only the effects of the high-intensity short-term EMST study in moderate OSAS patients were studied. High intensity and low intensity EMST has advantages and disadvantages.The study aims to compare the effects of high (60% MEP) and low (30% MEP) expiratory muscle strength training (EMST) on disease severity, sleep efficiency, snoring, fatigue severity and quality of life in severe OSAS patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 1, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

December 20, 2022

Status Verified

January 1, 2022

Enrollment Period

11 months

First QC Date

June 26, 2020

Last Update Submit

December 19, 2022

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

Expiratory muscle strength trainingSnoringSleep qualityEMST

Outcome Measures

Primary Outcomes (2)

  • Disease severity

    Polysomnography recordings will be taken especially sleep efficiency and apnea-hypopnea index (AHI). Higher sleep efficiency and lower AHI values shows that patient have better status and lower disease severity

    2 day

  • Respiratory muscle strength

    Maximal inspiratory and expiratory muscle strength measurement with mouth pressure device

    5 day

Secondary Outcomes (4)

  • Daytime sleepiness

    2 day

  • Snoring severitiy and frequency

    2 day

  • Sleep quality

    2 day

  • Fatigue severity.

    2 day

Other Outcomes (1)

  • Antropometric measurements

    2 day

Study Arms (2)

L-EMST

EXPERIMENTAL

At 30% of the maximum expiratory pressure (MEP), 25 breaths, 7 days / week, a total of 8 weeks will be trained once a day with a 1-minute rest cycle in 5 breaths. Patients will be invited to control every 2 weeks. MEP measurements will be repeated and the training value will be adjusted in 30% of the new measurement.

Other: Expiratory muscle trainig

H-EMST

ACTIVE COMPARATOR

In 60% of the maximum expiratory pressure (MEP), 25 breaths a day, 7 days / week, a total of 8 weeks will be trained with a 1-minute rest cycle in 5 breaths. Patients will be invited to control every 2 weeks. MEP measurements will be repeated and the training value will be adjusted in 60% of the new measurement.

Other: Expiratory muscle trainig

Interventions

Expiratory muscle trainigOTHER

This exercise will be used to strengthen forced expiratory muscles.

H-EMSTL-EMST

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients diagnosed with severe OSAS by Polysomnography in Ahi Evren Chest, Cardiovascular Surgery Training and Research Hospital Sleep Center will be included.
  • General health condition is stable

You may not qualify if:

  • Passed stroke,
  • Neurological disease and psychological disease
  • Cardiac disease
  • Hypothyroidism
  • Serious obstructive nasal disease,
  • A history of infection in the past month.
  • Previous oroferengeal surgery history
  • With a BMI of 40 kg / m2 or more,
  • Using substance, alcohol, sedative and hypnotic drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital

Trabzon, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSnoringSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesRespiratory SoundsSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Ebru Calik-Kutukcu, PhD

    Hacettepe University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Physiotherapist

Study Record Dates

First Submitted

June 26, 2020

First Posted

July 1, 2020

Study Start

June 1, 2021

Primary Completion

April 30, 2022

Study Completion

June 1, 2022

Last Updated

December 20, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)