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

NCT01553227 | Completed

• 1 other identifier: CXZZ11-0726
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Apnea, Obstructive; Obesity Hypoventilation Syndrome

Keywords

OSAHS: Obstructive Sleep Apnea hypopnea Syndrome; OHS: Obesity Hypoventilation Syndrome; Auto-trilevel ventilation; BiPAP ventilation

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Study Arms (1)

ventilator

EXPERIMENTAL

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

Interventions

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.

Also known as: Auto-trilevel ventilation

ventilator

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Obesity Hypoventilation Syndrome

Interventions

Ventilators, Mechanical

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• xilong zhang, MD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The First Affiliated Hospital of Nanjing Medical University

Study Record Dates

• First Submitted: March 8, 2012
• First Posted: March 14, 2012
• Study Start: August 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 27, 2012

Record last verified: 2012-11

Locations

CN (1)