Alternative of Treatment in Obesity Hypoventilation Syndrome

This study is currently recruiting participants. (see Contacts and Locations)

Verified December 2015 by Sociedad Española de Neumología y Cirugía Torácica

Sponsor:

Information provided by (Responsible Party):

Juan F. Masa, Sociedad Española de Neumología y Cirugía Torácica

ClinicalTrials.gov Identifier:

NCT01405976

First received: July 3, 2008

Last updated: April 19, 2016

Last verified: December 2015

History of Changes

Purpose

Primary objectives: evaluate the efficacy of noninvasive ventilation (NIV) treatment versus continuous positive airway pressure (CPAP) and the "historic" treatment (weight loss and oxygen) in Obesity Hipoventilation Syndrome (OHS), with PCO2 and days of hospitalization 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, and the incidence 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 historic treatment. The AHI <=30 groups will be randomized to NIV or historic 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.

Condition	Intervention	Phase
Obesity Hypoventilation Syndrome	Device: diet, oxygen, noninvasive ventilation, CPAP	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Mid-and Long-term Efficacy of Ventilation Non-invasive and Continuos Positive Airway Pressure in Obesity Hipoventilation Syndrome

Further study details as provided by Sociedad Española de Neumología y Cirugía Torácica:

Primary Outcome Measures:

Days of hospitalization [ Time Frame: at the end of two months and three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of Dropouts for Medical reasons and mortality [ Time Frame: two months, three years ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	440
Study Start Date:	November 2009
Estimated Study Completion Date:	July 2016
Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1	Device: diet, oxygen, noninvasive ventilation, CPAP diet, oxygen, noninvasive ventilation, CPAP
Active Comparator: 2	Device: diet, oxygen, noninvasive ventilation, CPAP diet, oxygen, noninvasive ventilation, CPAP
Active Comparator: 3	Device: diet, oxygen, noninvasive ventilation, CPAP diet, oxygen, noninvasive ventilation, CPAP
Active Comparator: 4	Device: diet, oxygen, noninvasive ventilation, CPAP diet, oxygen, noninvasive ventilation, CPAP
Active Comparator: 5	Device: diet, oxygen, noninvasive ventilation, CPAP diet, oxygen, noninvasive ventilation, CPAP

Detailed Description:

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

Eligibility


Ages Eligible for Study:	15 Years to 80 Years (Child, Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age between 15 and 80 years old.
Absence of moderate or severe chronic obstructive pulmonary disease (COPD).
Absence of neuromuscular, chest wall or metabolic disease which cause daytime hypercapnia.
Absence of narcolepsy or restless legs syndrome
Exceed correctly treatment of at least 30 minutes with CPAP/NIV at wakefulness.

Exclusion Criteria:

Psychophysical incapacity to answer questionnaires.
Patients who are not able to be evaluated by means of quality of life questionnaires for suffering restrictive chronic disease previously diagnosed (neoplasy, chronic pain of any origin, renal failure, severe chronic obstructive pulmonary disease and any other restrictive chronic disease).
Subjects with important chronic nasal obstruction that prevents from using CPAP/NIV.
Informed consent not obtained.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405976

Contacts


Contact: Juan F Masa, MD	34-927-256289	fmasa@separ.es

Locations


Spain
Hospital San Pedro de Alcántara. Servicio Extremeño de Salud	Recruiting
Cáceres, Spain, 10003
Contact: Juan F Masa, MD 34-927-256289 fmasa@separ.es

Sponsors and Collaborators

Sociedad Española de Neumología y Cirugía Torácica

Investigators


Principal Investigator:	Juan F Masa, MD	Hospital San Pedro de Alcántara. Cáceres. Spain

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Masa JF, Corral J, Alonso ML, Ordax E, Troncoso MF, Gonzalez M, Lopez-Martínez S, Marin JM, Marti S, Díaz-Cambriles T, Chiner E, Aizpuru F, Egea C; Spanish Sleep Network. Efficacy of Different Treatment Alternatives for Obesity Hypoventilation Syndrome. Pickwick Study. Am J Respir Crit Care Med. 2015 Jul 1;192(1):86-95. doi: 10.1164/rccm.201410-1900OC.


Responsible Party:	Juan F. Masa, MD, Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier:	NCT01405976 History of Changes
Other Study ID Numbers:	PI080346
Study First Received:	July 3, 2008
Last Updated:	April 19, 2016
Health Authority:	Spain: Ministry of Health and Consumption

Keywords provided by Sociedad Española de Neumología y Cirugía Torácica:


sleep apneas noninvasive ventilation CPAP

Additional relevant MeSH terms:


Obesity Syndrome Hypoventilation Obesity Hypoventilation Syndrome Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Disease Pathologic Processes	Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Sleep Apnea, Obstructive Sleep Apnea Syndromes Apnea Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases

ClinicalTrials.gov processed this record on September 23, 2016

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