Alternative of Treatment in Obesity Hypoventilation Syndrome

Status Completed

Clinical Trial Summary

Primary objectives: evaluate the efficacy of noninvasive ventilation (NIV) treatment versus continuous positive airway pressure (CPAP) and life style modification treatment in Obesity Hypoventilation Syndrome (OHS), with PCO2 (first phase) and days of hospitalization (second phase) analyzed as a primary variables and percentage of dropouts for medical reasons and mortality as operative variables. As secondary variables: Measure functional and clinical improvement during sleep and wakefulness, quality of life, echocardiography and the incidence and blood pressure and evolution of cardiovascular events. Objectives secondaries:role of apneogenic sleep events on molecular inflammation, endothelial damage and the genesis of diurnal hypercapnia. Methods:prospective, randomized controlled trial. Patients with OHS will be divided initially into two groups based on their apnea-hypopnea index (AHI) score, >=30 and < 30, using conventional polysomnography. The AHI >=30 group will be randomized to CPAP, NIV or life style modification treatments. The AHI <=30 groups will be randomized to NIV or life style modification treatments. Treatment efficacy at the medium- and long-term will be analyzed by comparing groups. The role of apneic events and leptin in the genesis of daytime alveolar hypoventilation will be analyzed by comparing the daytime PCO2/AHI coefficient between responders and non-responders to CPAP treatment, and the evolution of leptin levels in the four branches of the study. The role of apneic events in metabolic and biochemical alterations and endothelial dysfunction will be analyzed by comparing basal and post-treatment levels of related substances between groups, with and without significant AHI.

Clinical Trial Description

The AHI >=30 group will be analyzed to CPAP, NIV or life style modification treatments for two mouths.Once an evaluation is done during this period, the life style modification treatment will be randomized with the NIV/CPAP treatment for a continuation of three years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01405976
Study type	Interventional
Source	Sociedad Española de Neumología y Cirugía Torácica
Contact
Status	Completed
Phase	N/A
Start date	May 2009
Completion date	July 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01903135` - Prevalence of Obesity Hypoventilation Syndrome	N/A
Recruiting	`NCT04098094` - Outcomes of RV Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases
Withdrawn	`NCT03861468` - Medico-economics and QoL of Obese Patients Followed by Medical Analysis Laboratories (BIOSAOS )	N/A
Completed	`NCT01368614` - AVAPS-AE Efficacy Study	N/A
Terminated	`NCT01964339` - Obesity Hypoventilation Syndrome Prevalence Study
Completed	`NCT04108819` - Ketogenic Diet for Obesity Hypoventilation Syndrome	N/A
Completed	`NCT02934581` - Prevalence Rate, and Clinical Characteristics of Obesity Hypoventilation Syndrome Via Screening Patients Admitted to Medical Intensive Care Units
Terminated	`NCT03353064` - Telemedicine for Improving Outcome in Inner City Patient Population With Hypercapneic Respiratory Failure	N/A
Completed	`NCT03085537` - Effectiveness Monitoring of Home Non-invasive Mechanical Ventilation by Digital Diagnosis Platform
Recruiting	`NCT02980770` - Postoperative Complications in Patients With Obesity Hypoventilation Syndrome	N/A
Completed	`NCT01483716` - A Trial of Rehabilitation in Obesity Hypoventilation Syndrome (OHS)	N/A
Completed	`NCT01499485` - Treatment of Metabolic Alkalosis With Acetazolamide. Effect on the Length of Mechanical Ventilation.	Phase 3
Completed	`NCT03506906` - The Debated Role of Sleep Studies in Patients Under Established Home Mechanical Ventilation	N/A
Terminated	`NCT02317042` - Juno Perth Clinical Trial	N/A
Withdrawn	`NCT01104610` - Target Volume Mode Controlled Ventilator in Obesity Hypoventilation Syndrome	N/A
Recruiting	`NCT03854058` - Respiratory Muscle Strength in Patients With Obesity Hypoventilation Syndrome (OHS) or With a Precursor of the Disease
Not yet recruiting	`NCT05190458` - Evaluation of High Velocity Nasal Insufflation in Management of Respiratory Failure in Patients With Overlap Syndrome	N/A
Recruiting	`NCT04100616` - A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Obesity
Completed	`NCT02342899` - Cost Effectiveness of Outpatient Set-up of Automated NIV in Obese Patients With Chronic Respiratory Failure	Phase 3
Completed	`NCT01757444` - Non Invasive Ventilation : Efficacy of a New Ventilatory Mode in Patients With OHS	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.