Alternative of Treatment in Obesity Hypoventilation Syndrome

September 22, 2017 updated by: Juan F. Masa, Sociedad Española de Neumología y Cirugía Torácica

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Actual)

440

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Cáceres, Spain, 10003
        • Hospital San Pedro de Alcántara. Servicio Extremeño de Salud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
NIV for severe OSA group
Device: life style modification, noninvasive ventilation, CPAP
life style modification, noninvasive ventilation, CPAP
Active Comparator: 2
CPAP for severe OSA group
Device: life style modification, noninvasive ventilation, CPAP
life style modification, noninvasive ventilation, CPAP
Active Comparator: 3
Life stile modification for severe OSA group
Device: life style modification, noninvasive ventilation, CPAP
life style modification, noninvasive ventilation, CPAP
Active Comparator: 4
NIV for non-severe OSA group
Device: life style modification, noninvasive ventilation, CPAP
life style modification, noninvasive ventilation, CPAP
Active Comparator: 5
Life stile modification for non-severe OSA group
Device: life style modification, noninvasive ventilation, CPAP
life style modification, noninvasive ventilation, CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days of hospitalization
Time Frame: at least three years
Days of hospitalization
at least three years
PaCO2
Time Frame: at the end of first two months
PaCO2
at the end of first two months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Dropouts for Medical reasons and mortality
Time Frame: at least three years
Number of Dropouts for Medical reasons and mortality
at least three years
quality of life
Time Frame: two months and three years
quality of life
two months and three years
respiratory function
Time Frame: two months and three years
respiratory function
two months and three years
polysomnographic parameters
Time Frame: two months
polysomnographic parameters
two months
molecular inflammation and endothelial dysfunction
Time Frame: two months and three years
molecular inflammation and endothelial dysfunction
two months and three years
echocardiographic parameters
Time Frame: two months and three years
echocardiographic parameters
two months and three years
Blood pressure and new cardiovascular events
Time Frame: three years
Blood pressure and new cardiovascular events
three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sociedad Española de Neumología y Cirugía Torácica

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2009

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

July 3, 2008

First Submitted That Met QC Criteria

July 28, 2011

First Posted (Estimate)

July 29, 2011

Study Record Updates

Last Update Posted (Actual)

September 25, 2017

Last Update Submitted That Met QC Criteria

September 22, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI080346

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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