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OpenTrials
Completed

NCT Number: NCT01405976

Alternative of Treatment 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.

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Key information

Age range

15 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital San Pedro de Alcántara. Servicio Extremeño de Salud

Cáceres, 10003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

life style modification, noninvasive ventilation, CPAP

Device

life style modification, noninvasive ventilation, CPAP

Primary outcomes

  1. Days of hospitalization

    Time frame: at least three years

    Days of hospitalization

  2. PaCO2

    Time frame: at the end of first two months

    PaCO2

Secondary outcomes

  1. Number of Dropouts for Medical reasons and mortality

    Time frame: at least three years

    Number of Dropouts for Medical reasons and mortality

  2. quality of life

    Time frame: two months and three years

    quality of life

  3. respiratory function

    Time frame: two months and three years

    respiratory function

  4. polysomnographic parameters

    Time frame: two months

    polysomnographic parameters

  5. molecular inflammation and endothelial dysfunction

    Time frame: two months and three years

    molecular inflammation and endothelial dysfunction

  6. echocardiographic parameters

    Time frame: two months and three years

    echocardiographic parameters

  7. Blood pressure and new cardiovascular events

    Time frame: three years

    Blood pressure and new cardiovascular events

Sponsors and collaborators

Lead sponsor

Sociedad Española de Neumología y Cirugía Torácica

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2017
First posted
Jul 29, 2011
Registry last updated
Sep 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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