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Alternative of Treatment in Obesity Hypoventilation Syndrome

Primary Purpose

Obesity Hypoventilation Syndrome

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
life style modification, noninvasive ventilation, CPAP
Sponsored by
Sociedad Española de Neumología y Cirugía Torácica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity Hypoventilation Syndrome focused on measuring sleep apneas, noninvasive ventilation, CPAP

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital San Pedro de Alcántara. Servicio Extremeño de Salud

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

5

Arm Description

NIV for severe OSA group

CPAP for severe OSA group

Life stile modification for severe OSA group

NIV for non-severe OSA group

Life stile modification for non-severe OSA group

Outcomes

Primary Outcome Measures

Days of hospitalization
Days of hospitalization
PaCO2
PaCO2

Secondary Outcome Measures

Number of Dropouts for Medical reasons and mortality
Number of Dropouts for Medical reasons and mortality
quality of life
quality of life
respiratory function
respiratory function
polysomnographic parameters
polysomnographic parameters
molecular inflammation and endothelial dysfunction
molecular inflammation and endothelial dysfunction
echocardiographic parameters
echocardiographic parameters
Blood pressure and new cardiovascular events
Blood pressure and new cardiovascular events

Full Information

First Posted
July 3, 2008
Last Updated
September 22, 2017
Sponsor
Sociedad Española de Neumología y Cirugía Torácica
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1. Study Identification

Unique Protocol Identification Number
NCT01405976
Brief Title
Alternative of Treatment in Obesity Hypoventilation Syndrome
Official Title
Mid-and Long-term Efficacy of Ventilation Non-invasive and Continuos Positive Airway Pressure in Obesity Hypoventilation Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2009 (Actual)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sociedad Española de Neumología y Cirugía Torácica

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity Hypoventilation Syndrome
Keywords
sleep apneas, noninvasive ventilation, CPAP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
440 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
NIV for severe OSA group
Arm Title
2
Arm Type
Active Comparator
Arm Description
CPAP for severe OSA group
Arm Title
3
Arm Type
Active Comparator
Arm Description
Life stile modification for severe OSA group
Arm Title
4
Arm Type
Active Comparator
Arm Description
NIV for non-severe OSA group
Arm Title
5
Arm Type
Active Comparator
Arm Description
Life stile modification for non-severe OSA group
Intervention Type
Device
Intervention Name(s)
life style modification, noninvasive ventilation, CPAP
Intervention Description
life style modification, noninvasive ventilation, CPAP
Primary Outcome Measure Information:
Title
Days of hospitalization
Description
Days of hospitalization
Time Frame
at least three years
Title
PaCO2
Description
PaCO2
Time Frame
at the end of first two months
Secondary Outcome Measure Information:
Title
Number of Dropouts for Medical reasons and mortality
Description
Number of Dropouts for Medical reasons and mortality
Time Frame
at least three years
Title
quality of life
Description
quality of life
Time Frame
two months and three years
Title
respiratory function
Description
respiratory function
Time Frame
two months and three years
Title
polysomnographic parameters
Description
polysomnographic parameters
Time Frame
two months
Title
molecular inflammation and endothelial dysfunction
Description
molecular inflammation and endothelial dysfunction
Time Frame
two months and three years
Title
echocardiographic parameters
Description
echocardiographic parameters
Time Frame
two months and three years
Title
Blood pressure and new cardiovascular events
Description
Blood pressure and new cardiovascular events
Time Frame
three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan F Masa, MD
Organizational Affiliation
Hospital San Pedro de Alcántara. Cáceres. Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital San Pedro de Alcántara. Servicio Extremeño de Salud
City
Cáceres
ZIP/Postal Code
10003
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34755598
Citation
Masa JF, Benitez ID, Javaheri S, Mogollon MV, Sanchez-Quiroga MA, de Terreros FJG, Corral J, Gallego R, Romero A, Caballero-Eraso C, Ordax-Carbajo E, Troncoso MF, Gonzalez M, Lopez-Martin S, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Egea C, Barca J, Barbe F, Mokhlesi B; Spanish Sleep Network. Risk factors associated with pulmonary hypertension in obesity hypoventilation syndrome. J Clin Sleep Med. 2022 Apr 1;18(4):983-992. doi: 10.5664/jcsm.9760.
Results Reference
derived
PubMed Identifier
32343963
Citation
Masa JF, Benitez I, Sanchez-Quiroga MA, Gomez de Terreros FJ, Corral J, Romero A, Caballero-Eraso C, Alonso-Alvarez ML, Ordax-Carbajo E, Gomez-Garcia T, Gonzalez M, Lopez-Martin S, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Egea C, Barca J, Vazquez-Polo FJ, Negrin MA, Martel-Escobar M, Barbe 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.
Results Reference
derived
PubMed Identifier
32217780
Citation
Masa JF, Mokhlesi B, Benitez I, Gomez de Terreros Caro FJ, Sanchez-Quiroga MA, Romero A, Caballero C, Alonso-Alvarez ML, Ordax-Carbajo E, Gomez-Garcia T, Gonzalez M, Lopez-Martin S, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Egea C, Barca J, Vazquez-Polo FJ, Negrin MA, Martel-Escobar M, Barbe F, Corral-Penafiel 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.
Results Reference
derived
PubMed Identifier
31682462
Citation
Masa JF, Mokhlesi B, Benitez I, Mogollon MV, Gomez de Terreros FJ, Sanchez-Quiroga MA, Romero A, Caballero-Eraso C, Alonso-Alvarez ML, Ordax-Carbajo E, Gomez-Garcia T, Gonzalez M, Lopez-Martin S, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Egea C, Barca J, Vazquez-Polo FJ, Negrin 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.
Results Reference
derived
PubMed Identifier
30935737
Citation
Masa JF, Mokhlesi B, Benitez I, Gomez de Terreros FJ, Sanchez-Quiroga MA, Romero A, Caballero-Eraso C, Teran-Santos J, Alonso-Alvarez ML, Troncoso MF, Gonzalez M, Lopez-Martin S, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Egea C, Barca J, Vazquez-Polo FJ, Negrin 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.
Results Reference
derived
PubMed Identifier
29146865
Citation
Corral J, Mogollon MV, Sanchez-Quiroga MA, Gomez de Terreros J, Romero A, Caballero C, Teran-Santos J, Alonso-Alvarez ML, Gomez-Garcia T, Gonzalez M, Lopez-Martinez S, de Lucas P, Marin JM, Romero O, Diaz-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.
Results Reference
derived
PubMed Identifier
27568890
Citation
Masa JF, Corral J, Romero A, Caballero C, Teran-Santos J, Alonso-Alvarez ML, Gomez-Garcia T, Gonzalez M, Lopez-Martinez S, De Lucas P, Marin JM, Marti S, Diaz-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. doi: 10.5664/jcsm.6194.
Results Reference
derived
PubMed Identifier
27406165
Citation
Masa JF, Corral J, Caballero C, Barrot E, Teran-Santos J, Alonso-Alvarez ML, Gomez-Garcia T, Gonzalez M, Lopez-Martin S, De Lucas P, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Egea C, Miranda E, Mokhlesi B; Spanish Sleep Network; Garcia-Ledesma E, Sanchez-Quiroga MA, Ordax E, Gonzalez-Mangado N, Troncoso MF, Martinez-Martinez MA, Cantalejo O, Ojeda E, Carrizo SJ, Gallego B, Pallero M, Ramon MA, Diaz-de-Atauri J, Munoz-Mendez J, Senent C, Sancho-Chust JN, Ribas-Solis FJ, Romero A, Benitez JM, Sanchez-Gomez 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.
Results Reference
derived
PubMed Identifier
26923627
Citation
Masa JF, Corral J, Romero A, Caballero C, Teran-Santos J, Alonso-Alvarez ML, Gomez-Garcia T, Gonzalez M, Lopez-Martin S, De Lucas P, Marin JM, Marti S, Diaz-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.
Results Reference
derived
PubMed Identifier
25915102
Citation
Masa JF, Corral J, Alonso ML, Ordax E, Troncoso MF, Gonzalez M, Lopez-Martinez S, Marin JM, Marti S, Diaz-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.
Results Reference
derived

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Alternative of Treatment in Obesity Hypoventilation Syndrome

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