Treatment for Obstructive Sleep Apnea Hypopnea Syndrome and Obesity Hypoventilation Syndrome (OHS)

Sleep Apnea Hypopnea Syndrome (OSAHS), is common in patients with OHS, compared to single Obesity Hypoventilation Syndrome (OHS) or OSAHS ,patients with both of them are more susceptible to have serious hypoxia and carbon dioxide retention during sleep, and much more likely to result in pulmonary hypertension and cor-pulmonale.

At present, the most widely and valid method for these patients is the Bilevel Positive Airway Pressure (BiPAP) ventilation, while, recently, the investigators discovered a completely novel device, namely auto-trilevel Ventilator. In contrast to the traditional therapy, auto-trilevel Ventilator has a more flexible expiratory positive airway pressure (EPAP), with which it can removing residual obstructive sleep apnea hypopnea events and correcting hypercapnia without contradiction. Treated with auto-trilevel ventilator may delay the progression of disease and improve life quality. The overall purpose of this study is to determine the curative effects of auto-trilevel ventilators on patients with OHS and OSAHS.

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Key information

Conditions

Sleep Apnea, Obstructive Apnea Dyssomnias Hypoventilation Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity Hypoventilation Syndrome Overnutrition Overweight Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

About this study

The main contradiction in treatment for OSAHS complicated OHS is how to improve hypercapnia because of narrower difference between inspiratory positive airway pressure (IPAP) and expiratory positive airway pressure (EPAP), and meanwhile to eliminate apnea and popnea events which may easily occur at the end of expiration For ordinary Bipap ventilator. If the IPAP is set to higher, the patients may feel discomfort, if the pressure difference between IPAP and EPAP is too narrow or the expiratory positive airway pressure (EPAP) too high, hypercapnia may occur. If the EPAP is too low, redusual apnea and hypopnea event may become common.

Auto-trilevel ventilation, with a lower airway pressure at the beginning of expiration to prevent hypercapnia and a higher airway pressure at the end of expiration to prevent residual apnea events, should be able to provide a novel ventilation mode with a higher efficacy and lower average airway pressure for OSAHS patients complicated with OHS. To prove the hypothesis, comparison is made between ordinary BiPAP and auto-Trilevel ventilation modes during treatment for patients with OSAHS and OHS.

In this study, the investigators compare the changes of related indexes (including apnea hypopnea index、minimal pulse oxygen saturation、arousal index, sleep quality,PaCO2 and sleepiness scores) before and after treatment. Meanwhile, curative effects will be compared between BiPAP and auto-Trilevel ventilation modes. The investigators will analyze the changes and then confirm our hypothesis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient or legal representative of the patient is willing and able to sign an approved informed consent and privacy protection authorization in the United States.
Subject is >18 years old.
Diagnosed OHS and OSAHS:
Expected to tolerate the ventilator therapy.

Exclusion criteria

Patient is currently enrolled in another clinical study which may confound the result of this study.
Patient for whom inform consent cannot be obtained.
Patients with a history of cerebrovascular accident within the 6 months prior to this study.
Patients with acute or chronic renal failure, diabetes and severe lung diseases.
Patients with unstable angina.
Patient who is of pregnant or during lactation period.
Patients with a history of injury or surgery within 6 months prior to the study

Treatment and study plan

Ventilator

Device

Noninvasive ventilation including fixed BiPAP ventilation and auto-trilevel ventilation. Using the same IPAP, treatment include one night with BiPAP ventilation mode 1, one night with BiPAP ventilation mode 2 and one night with auto-trilevel ventilation mode. Each treatment last 8 hours for each night.

Other names: Auto-trilevel ventilation

Primary outcomes

Effect of auto-trilevel ventilation on patients with OSAHS and OHS

Time frame: Participants will be observed for the duration of hospital stay an expected average of 1 week

The overall purpose of this study is to determine the effects of auto-trilevel ventilator on patients with OSAHS and OHS. The following parameters are compared such as apnea hypopnea index, lowest SPO2, arousal index, sleep efficiency, PaCO2, daytime sleepiness and so on.

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Official study title

Effect of Auto-trilevel Ventilator on Patients With Obstructive Sleep Apnea Hypopnea Syndrome and Obesity

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Mar 14, 2012
Registry last updated: Nov 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed