Respiratory Muscle Endurance in Obesity Hypoventilation Syndrome

• ClinicalTrials.gov Identifier: NCT04835558
• Recruitment Status: Completed
• First Posted: April 8, 2021
• Last Update Posted: April 8, 2021
• Sponsor: Istanbul University
• Information provided by (Responsible Party): Goksen Kuran Aslan, Istanbul University-Cerrahpasa

Study Description

Brief Summary:

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.

Condition or disease
Obesity Hypoventilation Syndrome (OHS)

Detailed Description:

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 60 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Respiratory Muscle Endurance in Obesity Hypoventilation Syndrome; Evaluation by Incremental Load Test
• Actual Study Start Date: February 5, 2018
• Actual Primary Completion Date: November 5, 2018
• Actual Study Completion Date: January 24, 2019

Groups and Cohorts

Group/Cohort
Group I; Subjects with obesity hypoventilation sydrome (30 < body mass index < 40 kg/m2)
Group II; Subjects with obesity hypoventilation sydrome (body mass index > 40 kg/m2)
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)

Outcome Measures

Primary Outcome Measures :

1. Incremental load test [ Time Frame: 1 day ]
   Respiratory muscle endurance was evaluated by incremental load test. The incremental load test was performed using the electronic inspiratory loading device (PowerBreathe®-KHP2).

Secondary Outcome Measures :

1. Mouth pressure measurements [ Time Frame: 1 day ]
   Respiratory muscle strength was measured using mouth pressure measurements (Micro Medical MicroRPM).
2. 6 minute walk test [ Time Frame: 1 day ]
   The 6 minute walk test was used to evaluate the functional exercise capacity of the subjects.
3. Epworth Sleepiness Scale [ Time Frame: 1 day ]
   Excessive daytime sleepiness was assessed with the Epworth Sleepiness Scale. A score of >10 accepted as daytime sleepiness.
4. Pittsburg Sleep Quality Index [ Time Frame: 1 day ]
   Sleep quality was assessed with the Pittsburg Sleep Quality Index. The total score were interpreted as follows: 0-5 indicated good sleep quality, > 5 indicated poor sleep quality, and >10 indicated the presence of a sleep disorder.
5. Fatigue Severity Scale [ Time Frame: 1 day ]
   Fatigue severity was assessed with the Fatigue Severity Scale. This seven-likert scale was used for each item and final score was accepted as mean value of the 9 items. The higher scores indicated higher fatigue severity.
6. EQ-5D Health-Related Quality of Life Questionnaire [ Time Frame: 1 day ]
   Quality of life was assessed with the EQ-5D Health-Related Quality of Life Questionnaire. The maximum score of 1 indicates the best health state, and higher scores indicate more severe or frequent problems. In addition, there is a visual analogue scale (VAS) to indicate the general health status in which 100 indicates the best health status.
7. Obesity and Weight Loss Quality of Life Instrument [ Time Frame: 1 day ]
   Quality of life specific to obesity was assessed with the Obesity and Weight Loss Quality of Life Instrument. As the total score from the scale approaches 0, the quality of life decreases, and as it approaches 100, the quality of life increases.

Eligibility Criteria

• Ages Eligible for Study: 24 Years to 69 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

All subjects who had polysomnography performed in the sleep laboratory and were diagnosed with OHS were screened.

Age and sex-matched obese subjects (30 < body mass index < 40 kg/m2) with low risk of obstructive sleep apnea (STOP-BANG score < 3) included in the study as the control group.

Criteria

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

Contacts and Locations

Locations

Turkey

Istanbul University

Istanbul, Turkey

Sponsors and Collaborators

Istanbul University

More Information

• Responsible Party: Goksen Kuran Aslan, Assoc. Prof., Istanbul University-Cerrahpasa
• ClinicalTrials.gov Identifier: NCT04835558
• Other Study ID Numbers: 29713
• First Posted: April 8, 2021
• Last Update Posted: April 8, 2021
• Last Verified: April 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Goksen Kuran Aslan, Istanbul University-Cerrahpasa:

Respiratory Muscle Endurance; Sleep; Fatigue; Quality of Life

Additional relevant MeSH terms:

Hypoventilation; Obesity Hypoventilation Syndrome; Obesity; Syndrome; Disease; Pathologic Processes; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases