Alternative of Treatment in Obesity Hypoventilation Syndrome

Obesity Hypoventilation Syndrome Clinical Trial

Official title:

Mid-and Long-term Efficacy of Ventilation Non-invasive and Continuos Positive Airway Pressure in Obesity Hypoventilation Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01405976
• Other study ID #: PI080346
• Status: Completed
• Phase: N/A
• First received: July 3, 2008
• Last updated: September 22, 2017
• Start date: May 2009
• Est. completion date: July 2017

Study information

• Verified date: January 2017
• Source: Sociedad Española de Neumología y Cirugía Torácica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: July 2017
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypoventilation
• Obesity
• Obesity Hypoventilation Syndrome
• Syndrome

Intervention

Device:
• life style modification, noninvasive ventilation, CPAP
life style modification, noninvasive ventilation, CPAP

Locations

Country	Name	City	State
Spain	Hospital San Pedro de Alcántara. Servicio Extremeño de Salud	Cáceres

Sponsors (1)

Lead Sponsor	Collaborator
Sociedad Española de Neumología y Cirugía Torácica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days of hospitalization	Days of hospitalization	at least three years
Primary	PaCO2	PaCO2	at the end of first two months
Secondary	Number of Dropouts for Medical reasons and mortality	Number of Dropouts for Medical reasons and mortality	at least three years
Secondary	quality of life	quality of life	two months and three years
Secondary	respiratory function	respiratory function	two months and three years
Secondary	polysomnographic parameters	polysomnographic parameters	two months
Secondary	molecular inflammation and endothelial dysfunction	molecular inflammation and endothelial dysfunction	two months and three years
Secondary	echocardiographic parameters	echocardiographic parameters	two months and three years
Secondary	Blood pressure and new cardiovascular events	Blood pressure and new cardiovascular events	three years