Alternative of Treatment in Obesity Hypoventilation Syndrome

• ClinicalTrials.gov Identifier: NCT01405976
• Recruitment Status: Completed
• First Posted: July 29, 2011
• Last Update Posted: September 25, 2017
• Sponsor: Sociedad Española de Neumología y Cirugía Torácica
• Information provided by (Responsible Party): Juan F. Masa, Sociedad Española de Neumología y Cirugía Torácica

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Obesity Hypoventilation Syndrome	Device: life style modification, noninvasive ventilation, CPAP	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 440 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Mid-and Long-term Efficacy of Ventilation Non-invasive and Continuos Positive Airway Pressure in Obesity Hypoventilation Syndrome
• Actual Study Start Date: May 2009
• Actual Primary Completion Date: May 2013
• Actual Study Completion Date: July 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 80 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

Spain

Hospital San Pedro de Alcántara. Servicio Extremeño de Salud

Cáceres, Spain, 10003

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, Benítez I, Sánchez-Quiroga MÁ, Gomez de Terreros FJ, Corral J, Romero A, Caballero-Eraso C, Alonso-Álvarez ML, Ordax-Carbajo E, Gomez-Garcia T, González M, López-Martín S, Marin JM, Martí S, Díaz-Cambriles T, Chiner E, Egea C, Barca J, Vázquez-Polo FJ, Negrín MA, Martel-Escobar M, Barbé F, Mokhlesi B; Spanish Sleep Network. Long-term Noninvasive Ventilation in Obesity Hypoventilation Syndrome Without Severe OSA: The Pickwick Randomized Controlled Trial. Chest. 2020 Sep;158(3):1176-1186. doi: 10.1016/j.chest.2020.03.068. Epub 2020 Apr 25.

Masa JF, Mokhlesi B, Benítez I, Gómez de Terreros Caro FJ, Sánchez-Quiroga MÁ, Romero A, Caballero C, Alonso-Álvarez ML, Ordax-Carbajo E, Gómez-García T, González M, López-Martín S, Marin JM, Martí S, Díaz-Cambriles T, Chiner E, Egea C, Barca J, Vázquez-Polo FJ, Negrín MA, Martel-Escobar M, Barbé F, Corral-Peñafiel J; Spanish Sleep Network. Cost-effectiveness of positive airway pressure modalities in obesity hypoventilation syndrome with severe obstructive sleep apnoea. Thorax. 2020 Jun;75(6):459-467. doi: 10.1136/thoraxjnl-2019-213622. Epub 2020 Mar 26.

Masa JF, Mokhlesi B, Benítez I, Mogollon MV, Gomez de Terreros FJ, Sánchez-Quiroga MÁ, Romero A, Caballero-Eraso C, Alonso-Álvarez ML, Ordax-Carbajo E, Gomez-Garcia T, González M, López-Martín S, Marin JM, Martí S, Díaz-Cambriles T, Chiner E, Egea C, Barca J, Vázquez-Polo FJ, Negrín MA, Martel-Escobar M, Barbe F, Corral J; Spanish Sleep Network. Echocardiographic Changes with Positive Airway Pressure Therapy in Obesity Hypoventilation Syndrome. Long-Term Pickwick Randomized Controlled Clinical Trial. Am J Respir Crit Care Med. 2020 Mar 1;201(5):586-597. doi: 10.1164/rccm.201906-1122OC.

Masa JF, Mokhlesi B, Benítez I, Gomez de Terreros FJ, Sánchez-Quiroga MÁ, Romero A, Caballero-Eraso C, Terán-Santos J, Alonso-Álvarez ML, Troncoso MF, González M, López-Martín S, Marin JM, Martí S, Díaz-Cambriles T, Chiner E, Egea C, Barca J, Vázquez-Polo FJ, Negrín MA, Martel-Escobar M, Barbe F, Corral J; Spanish Sleep Network. Long-term clinical effectiveness of continuous positive airway pressure therapy versus non-invasive ventilation therapy in patients with obesity hypoventilation syndrome: a multicentre, open-label, randomised controlled trial. Lancet. 2019 Apr 27;393(10182):1721-1732. doi: 10.1016/S0140-6736(18)32978-7. Epub 2019 Mar 29.

Corral J, Mogollon MV, Sánchez-Quiroga MÁ, Gómez de Terreros J, Romero A, Caballero C, Teran-Santos J, Alonso-Álvarez ML, Gómez-García T, González M, López-Martínez S, de Lucas P, Marin JM, Romero O, Díaz-Cambriles T, Chiner E, Egea C, Lang RM, Mokhlesi B, Masa JF; Spanish Sleep Network. Echocardiographic changes with non-invasive ventilation and CPAP in obesity hypoventilation syndrome. Thorax. 2018 Apr;73(4):361-368. doi: 10.1136/thoraxjnl-2017-210642. Epub 2017 Nov 16.

Masa JF, Corral J, Romero A, Caballero C, Terán-Santos J, Alonso-Álvarez ML, Gomez-Garcia T, González M, López-Martínez S, De Lucas P, Marin JM, Marti S, Díaz-Cambriles T, Chiner E, Merchan M, Egea C, Obeso A, Mokhlesi B; Spanish Sleep Network. The Effect of Supplemental Oxygen in Obesity Hypoventilation Syndrome. J Clin Sleep Med. 2016 Oct 15;12(10):1379-1388.

Masa JF, Corral J, Caballero C, Barrot E, Terán-Santos J, Alonso-Álvarez ML, Gomez-Garcia T, González M, López-Martín S, De Lucas P, Marin JM, Marti S, Díaz-Cambriles T, Chiner E, Egea C, Miranda E, Mokhlesi B; Spanish Sleep Network, García-Ledesma E, Sánchez-Quiroga MÁ, Ordax E, González-Mangado N, Troncoso MF, Martinez-Martinez MÁ, Cantalejo O, Ojeda E, Carrizo SJ, Gallego B, Pallero M, Ramón MA, Díaz-de-Atauri J, Muñoz-Méndez J, Senent C, Sancho-Chust JN, Ribas-Solís FJ, Romero A, Benítez JM, Sanchez-Gómez J, Golpe R, Santiago-Recuerda A, Gomez S, Bengoa M. Non-invasive ventilation in obesity hypoventilation syndrome without severe obstructive sleep apnoea. Thorax. 2016 Oct;71(10):899-906. doi: 10.1136/thoraxjnl-2016-208501. Epub 2016 Jul 12.

Masa JF, Corral J, Romero A, Caballero C, Terán-Santos J, Alonso-Álvarez ML, Gomez-Garcia T, González M, López-Martín S, De Lucas P, Marin JM, Marti S, Díaz-Cambriles T, Chiner E, Merchan M, Egea C, Obeso A, Mokhlesi B; Spanish Sleep Network(∗). Protective Cardiovascular Effect of Sleep Apnea Severity in Obesity Hypoventilation Syndrome. Chest. 2016 Jul;150(1):68-79. doi: 10.1016/j.chest.2016.02.647. Epub 2016 Feb 27.

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
• Other Study ID Numbers: PI080346
• First Posted: July 29, 2011
• Last Update Posted: September 25, 2017
• Last Verified: January 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Juan F. Masa, Sociedad Española de Neumología y Cirugía Torácica:

sleep apneas; noninvasive ventilation; CPAP

Additional relevant MeSH terms:

Hypoventilation; Obesity Hypoventilation Syndrome; Obesity; Syndrome; Disease; Pathologic Processes; Overnutrition; Nutrition Disorders; Overweight; Body Weight; 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