Respiratory Muscle Strength in Patients With Obesity Hypoventilation Syndrome (OHS) or With a Precursor of the Disease

Wissenschaftliches Institut Bethanien e.V

Status: Enrolling

Conditions: Obesity Hypoventilation Syndrome

Treatments: Diagnostic Test: magnetic phrenic nerve stimulation

Study type: Observational

Funder types: Other

Identifiers

NCT03854058

WI_18-340

Details and patient eligibility

About

Using an extensive set of both volitional and non-volitional tests of respiratory muscle function and strength it is the aim of this study to

• identify potential determinants for the development of obesity hypoventilation
• to identify predictors for the presence of a sleep-related hypoventilation requiring treatment in obese patients

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with BMI > 30 and obesity-associated hypoventilation stages I - IV
• patients with BMI > 30 and elevated OHS-risk (= obstructive sleep apnea without hypercapnia)
• age:18-80 years
• capacity to consent

Exclusion criteria

• any other disease, that causes ventilatory insufficiency
• pacemaker, defibrillators or device for deep brain or vagus nerve stimulation
• esophagitis, Barrett-esophagus, esophageal cancer
• acute gastritis and ulcera ventriculi
• epilepsy
• any medical, psychological or other condition impairing the patient's ability to provide informed consent

Trial design

50 participants in 1 patient group

OHS or elevated OHS-risk (stages 0-IV)

Description:

stage 0: OHS-risk (OSA / no hypercapnia) stage I: obesity associated hypoventilation (intermittent hypercapnia during sleep, arterial carbon dioxide partial pressure (PaCO2) or transcutaneous carbon dioxide partial pressure (PtcCO2) morning \~ evening), bicarbonate \< 27 mmol/L awake) stage II: obesity associated hypoventilation (intermittent hypercapnia during sleep, PaCO2 or PtcCO2 morning \> evening, bicarbonate ≥ 27 mmol/L awake) stage III: OHS (hypercapnia, carbon dioxide partial pressure (PCO2) \> 45 mmHg awake) stage IV: OHS with end organ damage (hypercapnia , PCO2 \> 45 mmHg awake, cardiometabolic comorbidities) diagnostic tests: magnetic phrenic nerve stimulation, diaphragmatic ultrasound

Treatment:

Diagnostic Test: magnetic phrenic nerve stimulation