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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zhang Xilong, Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT01553227
First received: March 8, 2012
Last updated: November 26, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Sleep Apnea, Obstructive
Obesity Hypoventilation Syndrome
 Device: ventilator

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Auto-trilevel Ventilator on Patients With Obstructive Sleep Apnea Hypopnea Syndrome and Obesity

Resource links provided by NLM:

MedlinePlus related topics: Obesity Sleep Apnea
U.S. FDA Resources

Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 24
Study Start Date: August 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ventilator
The overall purpose of this study is to determine the effects of auto-Trilevel ventilation on patients with OSAHS and OHS by comparison with BiPAP ventilation. The following parameters are compared such as apnea hypopnea index, lowest SPO2, arousal index, sleep efficiency, PaCO2, daytime sleepiness and so on.
 Device: ventilator
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 Name: Auto-trilevel ventilation

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Subject is >18 years old.
  3. Diagnosed OHS and OSAHS:
  4. Expected to tolerate the ventilator therapy.

Exclusion Criteria:

  1. Patient is currently enrolled in another clinical study which may confound the result of this study.
  2. Patient for whom inform consent cannot be obtained.
  3. Patients with a history of cerebrovascular accident within the 6 months prior to this study.
  4. Patients with acute or chronic renal failure, diabetes and severe lung diseases.
  5. Patients with unstable angina.
  6. Patient who is of pregnant or during lactation period.
  7. Patients with a history of injury or surgery within 6 months prior to the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01553227

Locations
China, Jiangsu
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Sponsors and Collaborators
Nanjing Medical University
Investigators
Principal Investigator: xilong zhang, MD The First Affiliated Hospital of Nanjing Medical University
  More Information

No publications provided

Responsible Party: Zhang Xilong, The First Affiliated Hospital of Nanjing Medical University, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01553227     History of Changes
Other Study ID Numbers: CXZZ11-0726
Study First Received: March 8, 2012
Last Updated: November 26, 2012
Health Authority: China: Ethics Committee

Keywords provided by Nanjing Medical University:
OSAHS: Obstructive Sleep Apnea hypopnea Syndrome
OHS: Obesity Hypoventilation Syndrome
Auto-trilevel ventilation
BiPAP ventilation

Additional relevant MeSH terms:
Apnea
Obesity
Obesity Hypoventilation Syndrome
Sleep Apnea Syndromes
Hypoventilation
Respiratory Insufficiency
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013