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Respiratory Muscle Endurance in Obesity Hypoventilation Syndrome

NCT ID: NCT04835558

Last Updated: 2021-04-08

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

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-05

Study Completion Date

2019-01-24

Brief Summary

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Obesity hypoventilation syndrome (OHS) is defined as a combination of obesity \[body mass index (BMI) ≥30 kg/m2\], chronic daytime hypercapnia (PaCO2 \>45 mm Hg), and sleep-apnea in the absence of other known causes of hypercapnia. Respiratory system compliance decreases and resistance increases in OHS. This causes increase in work of breathing and oxygen cost of breathing, which may result in respiratory muscle fatigue. Increase in respiratory workload and increase in resistance to respiration is expected to decrease in respiratory muscle endurance (RME) in subjects with OHS.

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Detailed Description

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In the literature, studies evaluating RME in subjects with OHS are limited. No study has been found to evaluate RME using the incremental load test in subjects with OHS. Accordingly, it was aimed to evaluate and compare respiratory muscle endurance in subjects with OHS and a control group, and to determine factors associated with respiratory muscle endurance.

Conditions

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Obesity Hypoventilation Syndrome (OHS)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group I

Subjects with obesity hypoventilation sydrome (30 \< body mass index \< 40 kg/m2)

No interventions assigned to this group

Group II

Subjects with obesity hypoventilation sydrome (body mass index \> 40 kg/m2)

No interventions assigned to this group

Control Group

Age and sex-matched obese subjects (30 \< body mass index \< 40 kg/m2) with low risk of obstructive sleep apnea (STOP-BANG score \< 3)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with OHS
* Obese subjects (30 \< body mass index \< 40 kg/m2) with low risk of obstructive sleep apnea (STOP-BANG score \< 3)

Exclusion Criteria

* Severe respiratory disease
* Subjects with orthopeadic and/or neurologic disorders that could limit exercise tests
Minimum Eligible Age

24 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Goksen Kuran Aslan

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istanbul University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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29713

Identifier Type: -

Identifier Source: org_study_id

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