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due to the "Philips alert " we could not get the treatment equipment and the public grands expired
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| Name | Class |
|---|---|
| Rush University Medical Center | OTHER |
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We propose to carry out a large multicentric, multinational, randomized controlled trial with two phases (two sequential randomized controled trials) to answer two questions: 1) Should hospitalized patients with recently diagnosed OHS be discharged from the hospital on an auto-titratable NIV treatment until the diagnosis of OHS is confirmed in 3 months? 2) Is the long-term effectiveness of outpatient titrated CPAP non-inferior to titrated NIV in ambulatory patients with OHS 3 months after hospital discharge? Clinical practice, multicenter open-label controlled randomized clinical trial with preset allocation rate (1:1) with two parallel-groups conducted in centers from Spain, France, Portugal and USA. The study will have two phases with two randomizations. The first phase will be a superiority study and the second phase will be a non-inferiority study.
Objectives: First phase (medium-term): To evaluate the medium-term (3 months) efficacy of automatically adjusted noninvasive ventilation (NIV) treatment versus "life style modifications" treatment in obesity hypoventilation syndrome (OHS) after an episode of acute-on-chronic hypercapnic respiratory failure. The main outcome will be a composite that includes hospital resource utilization (hospital and ICU admissions and emergency department visits for any cause) and all-cause mortality. Key secondary outcomes will include incident cardiovascular events (new hypertension diagnosis or initiation of anti-hypertensive treatment, atrial fibrillation, hospitalization for nonfatal myocardial infarction or unstable angina, percutaneous coronary interventions, nonfatal stroke or transient ischemic attack or for acute heart failure episode, and cardiovascular death), blood pressure, arterial blood gases, clinical symptoms and quality of life. Second phase (long-term): Evaluate the long-term efficacy (36 months) of manually titrated NIV treatment versus manually titrated CPAP treatment in OHS after 3 months of an episode of acute-on-chronic hypercapnic respiratory failure, with a composite outcome of hospital resource utilization (hospital and ICU admissions, emergency department visits) and all-cause mortality analyzed as the primary outcome. Incident cardiovascular events, blood pressure, arterial blood gases, clinical symptoms and quality of life will be the main secondary outcomes.
Methods: Prospective, multinational, randomized open-label controlled trial with two parallel arms: 1,110 hospitalized patients with newly diagnosed OHS with acute-on-chronic hypercapnic respiratory failure treated with invasive or noninvasive mechanical ventilation who survive hospitalization and available for hospital discharge will be randomized to either automatically adjusted NIV (555 patients) or "life style modifications" (555 patients) for three months. Subsequently, both automatically adjusted NIV and "life style modifications" arms will be re-randomized to polysomnographically adjusted CPAP or to polysomnographically adjusted NIV groups to complete 36 months of follow up. The first phase of the proposal is a superiority study and the second phase is a non-inferiority study. The primary outcome and its components will be analyzed by a mixed-effects model with negative binomial. A mixed-effects Cox model will be used for hospital resource utilization, new cardiovascular events and overall survival. Other secondary outcomes such as repeated measures derived from the arterial blood gases (i.e. PaCO2, PaO2, pH, calculated bicarbonate), blood pressure, health-related quality of life tests and Epworth Sleepiness Scale during the follow-up will be analyzed by a linear mixed-effects model.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Life style modification | Experimental | "Lifestyle modifications" group (Control) will consist of a 1,000-calorie/day diet and to maintain proper sleep hygiene and habits (avoid supine decubitus position, maintain regular sleep habits and exercise, not take sedatives, stimulants, alcohol, tobacco or heavy meals within four hours before bedtime). Oxygen therapy can be prescribed by the treating team using standard criteria (awake PaO2 <55 mmHg or room air oxygen saturation below 88% (Masa JF et al. J Clin Sleep Med. 2016 ;12:1379-88) |
|
| Life style modificacion and automatic NIV(AVAPS-AE) | Active Comparator | Automatic NIV: In addition to lifestyle modification and oxygen (if required), the ventilator will be adjusted to a range of predetermined parameters with the intelligent ventilation mode (pressure of intelligent support with guaranteed volume with automatic backup frequency) with the following adjustment: maximum pressure: 35 cmH2O; respiratory rate: automatic; maximum pressure support: 20 cm H2O; minimum pressure support: 4 cmH2O; maximum EPAP pressure: 15 cmH2O; minimum EPAP pressure: 4 cmH2O; and tidal volume (Vt) based on 8-10 ml/kg of predicted body weight. These parameters may be modified according to patient tolerance or non-compensated leak. |
|
| Life style modification and titrated NIV(S/T mode) | Experimental | In-laboratory polysomnographic NIV titration will be performed according to published guidelines (Berry R et al JCSM 2010). In addition to lifestyle modification and oxygen (if required), home NIV therapy with fixed pressures will be started. The ventilator mode will be a bilevel PAP with backup respiratory rate (BIPAP S/T mode). The ventilator adjustment will be firstly performed in awake situation and then during sleep by means of a PSG. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Lifestyle modifications" group (Control) | Procedure | It will consist of a 1,000-calorie/day diet and to maintain proper sleep hygiene and habits (avoid supine decubitus position, maintain regular sleep habits and exercise, not take sedatives, stimulants, alcohol, tobacco or heavy meals within four hours before bedtime). Oxygen therapy can be prescribed by the treating team using standard criteria (awake PaO2 <55 mmHg or room air oxygen saturation below 88% (Masa JF et al. J Clin Sleep Med. 2016 ;12:1379-88). The treatment period will be three months. |
| Measure | Description | Time Frame |
|---|---|---|
| Medium-term composite hospital resource utilization-mortality | Primary (medium-term from the first phase or RCT): the medium-term efficacy of automatic NIV treatment versus "lifestyle modifications" treatment in OHS measuring as primary outcome a composite including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events | 3 months |
| Long-term composite hospital resource utilization-mortality | Primary (long-term from the second phase or RCT): the long-term efficacy of titrated CPAP therapy versus titrated NIV therapy in OHS measuring as primary outcome a composite including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital admissions | Separately the components of the primary outcome: hospital admissions measured as the number of events | During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| ICU admissions |
| Measure | Description | Time Frame |
|---|---|---|
| A composite outcome in adherent vs. non-adherent to PAP therapy subgroups | Efficacy of automatic NIV treatment versus "lifestyle modifications" treatment measuring a composite outcome including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events comparing adherent vs. non-adherent to PAP therapy subgroups (lower and higher of a mean of 4 h/day) |
Inclusion Criteria:
[*] Patients who have objective evidence of minimal PAP therapy during the 6 months prior to hospital admission (i.e. average daily use of less than 2 hours of PAP therapy) can also be enrolled at the discretion of the investigators if they feel the patient is now more interested in being adherent to NIV therapy.
Inclusion criteria for the second phase of the study:
1º.- Included three months ago in the first phase of the study (followed by a washout period of 5 days).
Exclusion Criteria:
Exclusion criteria for the first phase of the study:
[‡] This prohibition shall be maintained for the duration of the patients' participation in the study. This is because, if patients received other treatments, it could be difficult to interpret the causality of the results obtained (whether beneficial or harmful effects) and the possible contraindications.
vi. Exclusion criteria for the second phase of the study:
1º.- With apnea hypopnea index (AHI) lower than 5 (absence or very mild obstructive sleep apnea).
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| Name | Affiliation | Role |
|---|---|---|
| Juan F Masa, MD, Phd | Servicio Extremeño de Salud | Principal Investigator |
| Babak Mokhlesi, MD, Prof | Rush University Medical Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16963680 | Background | Storre JH, Seuthe B, Fiechter R, Milioglou S, Dreher M, Sorichter S, Windisch W. Average volume-assured pressure support in obesity hypoventilation: A randomized crossover trial. Chest. 2006 Sep;130(3):815-21. doi: 10.1378/chest.130.3.815. | |
| 11029353 | Result | Masa JF, Rubio M, Findley LJ. Habitually sleepy drivers have a high frequency of automobile crashes associated with respiratory disorders during sleep. Am J Respir Crit Care Med. 2000 Oct;162(4 Pt 1):1407-12. doi: 10.1164/ajrccm.162.4.9907019. |
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Additional related documents such as study protocol, statistical analysis plan, and informed consent form will be available upon request from the Project principal investigator (Dr. Juan Fernando Masa). Deidentified patients' data can be requested by researchers for use in independent scientific research and will be provided following review and approval of the research proposal (including statistical analysis plan) and completion of a data sharing agreement with the Project Publications Committee. Investigator Data requests can be made anytime from 1 to 2 years after the publication of this trial. Requests should be sent to the corresponding author (Dr. Juan Fernando Masa- fmasa@separ.es).
2 years after the publication of this tria
Requests should be sent to the corresponding authors (Dr. Juan Fernando Masa- fmasa@separ.es; and Dr Babak Mokhlesi- Babak_Mokhlesi@rush.edu).
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| ID | Term |
|---|---|
| D010845 | Obesity Hypoventilation Syndrome |
| D012131 | Respiratory Insufficiency |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
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Prospective, open label, randomized controlled trial with two sequential phases
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|
| Life style modification and titrated CPAP | Active Comparator | In-laboratory polysomnographic CPAP titration will be performed according to published guidelines (SEPAR guideline or AASM guideline). In addition to lifestyle modification and oxygen (if required), home CPAP therapy at a fixed pressure will be initiated. |
|
|
| Automatic NIV | Procedure | In addition to lifestyle modification and oxygen (if required), the ventilator will be adjusted to a range of predetermined parameters with the intelligent ventilation mode (pressure of intelligent support with guaranteed volume with automatic backup frequency) with the following adjustment: maximum pressure: 35 cmH2O; respiratory rate: automatic; maximum pressure support: 18 cm H2O; minimum pressure support: 4 cmH2O; maximum EPAP pressure: 15 cmH2O; minimum EPAP pressure: 4 cmH2O; and tidal volume (Vt) based on 8-10 ml/kg of predicted body weight, being able to be modified according to tolerance.The treatment period will be three months. |
|
| CPAP treatment group | Procedure | In-laboratory polysomnographic CPAP titration will be performed according to published guidelines for CPAP titration (SEPAR guideline or AASM guideline).In addition to lifestyle modification and oxygen (if require), a home titrated CPAP therapy will be initiated.The treatment period will be three years. |
|
| NIV treatment groups | Procedure | In-laboratory polysomnographic NIV titration will be performed according to published guidelines In addition to lifestyle modification and oxygen (if required) home NIV therapy with fixed pressures will be started. The ventilator mode will be a bilevel pressure in S/T mode. The ventilator adjustment will be firstly performed in awake situation and then during sleep by means of a PSG. The treatment period will be three years. |
|
Separately the components of the primary outcome: ICU admissions measured as the number of events
| During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| Emergency department visits | Separately the components of the primary outcome: emergency department visits for any cause measured as the number of events | During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| All-cause mortality | Separately the components of the primary outcome: All-cause mortality number | During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| Duration of hospital admissions | Duration of hospital admissions measured in days of hospital admission | During 3 months and during 3 years for the first and second phase or sequential RCTs respectively |
| Duration of ICU admissions | Duration of ICU admissions measured in days of ICU admission | During 3 months and during 3 years for the first and second phase or sequential RCTs respectively |
| Number of patients who change of the allocated arms | Number of patients who change of the allocated arms | During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| Causes of change of the allocated treatment | Causes of change of the allocated arms | During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| Clinical symptoms: lower extremity edema | Number of patients into four levels of frequency (no, sometimes, usually and always) | During 3 months and during 3 years for first and second phases or sequential RCTs respectively |
| Clinical symptoms: unrefreshing sleep | Number of patients into four levels of frequency (no, sometimes, usually and always) | During 3 months and during 3 years for first and second phases or sequential RCTs respectively |
| Clinical symptoms: morning fatigue | Number of patients into four levels of frequency (no, sometimes, usually and always) | During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| Clinical symptoms: nocturia | Number of patients into four levels of frequency (no, sometimes, usually and always) | During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| Clinical symptoms: headache | Number of patients into four levels of frequency (no, sometimes, usually and always) | During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| Clinical symptoms: tiredness | Number of patients into four levels of frequency (no, sometimes, usually and always) | During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| Clinical symptoms: morning confusion | Number of patients into four levels of frequency (no, sometimes, usually and always) | During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| Clinical symptoms: dysnea | Number of patients with dysnea according to the Medical Research Council scale classified into five levels of intensity (from 0 to 4) | During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| Clinical symptoms: sleepiness | Level of perceived sleepiness measured by the Epworth Sleepiness Scale | During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| Health related quality of life (HRQL): Functional Outcomes of Sleep Questionnaire-- FOSQ-- | Scoring of Functional Outcomes of Sleep Questionnaire-- FOSQ--- | During 3 months and during 3 years for first and second phases or sequential RCTs respectively |
| Health related quality of life (HRQL): European health-related quality of life questionnaire (EuroQol) EQ-5D-5L | Scoring of European health-related quality of life questionnaire (EuroQol) EQ-5D-5L | During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| Health related quality of life (HRQL): Subjective state of illness on a visual analogical scale: Visual Analogical Well-being Scale -VAWS (Masa JF et al. Sleep Breath. 2011;15:549-59) (EuroQol) EQ-5D-5L | Scoring of Subjective state of illness on a visual analogical scale: Visual Analogical Well-being Scale -VAWS (Masa JF et al. Sleep Breath. 2011;15:549-59) measured in percentage. | During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| Arterial blood gases (ABG): PaO2 | PaO2 in mmHg | During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| Arterial blood gases (ABG): PaCO2 | PaCO2 in mmHg | During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| Arterial blood gases (ABG): Bicarbonate | bicarbonate measured in mmol/L | During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| Arterial blood gases (ABG): pH | pH | During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| Weight | weight in Kg | During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| Standardized blood pressure measures | Systolic and diastolic blood pressure measured in mmHg | During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| Incidence of cardiovascular events: systemic hypertension | Incidence of hypertension diagnosis or initiation of a new anti-hypertensive treatment | During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| Incidence of cardiovascular events: arrhythmia | Incidence of arrhythmia | During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| Incidence of cardiovascular events: nonfatal myocardial infarction | Incidence of nonfatal myocardial infarction | During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| Incidence of cardiovascular events: hospitalization for unstable angina | Incidence of hospitalization for unstable angina | During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| Incidence of cardiovascular events: coronary percutaneous interventions | Incidence of coronary percutaneous interventions | After 3 months and after 3 years for first and second phases or sequential RCTs respectively |
| Incidence of cardiovascular events: nonfatal stroke or transient ischemic attack | Incidence of nonfatal stroke or transient ischemic attack | During 3 months and during 3 years for first and second phases or sequential RCTs respectively |
| Incidence of cardiovascular events: heart failure episode | Incidence of heart failure episode | During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| Incidence of cardiovascular events: cardiovascular death | Incidence of cardiovascular death. | During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| Incidence of adverse event | Number of adverse events according to Treatment-Related Adverse Events as assessed by CTCAE v5.0 | During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| Cost-effectiveness analysis based on the primary outcome and quality adjusted life year (QALY) | Differences in within trial costs will be related with the differences in effectiveness (primary outcome and QALY) between arms using a probabilistic approach to calculate the cost-effectiveness plane. | During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| Number of oro-tracheal intubation | Number of the tracheal intubations | During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| Duration of tracheal intubation | Duration of tracheal intubation | During 3 months and during 3 years for the first and second phases or sequential RCTs respectively |
| During 3 months for the first phase or RCT |
| A composite outcome in adherent vs. non-adherent to PAP therapy subgroups | Efficacy of automatic NIV treatment versus CPAP treatment measuring a composite outcome including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events comparing adherent vs. non-adherent to PAP therapy subgroups (lower and higher of a mean of 4 h/days) | During 3 years for the second phase or RCT |
| Subgroups according to whether hypercapnia was resolved or not | Comparative efficacy between treatment arms measuring a composite outcome including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events in the subgroups with PaCO2 higher or lower of 45 mmHg at the end of follow-up | During 3 months and during 3 years for first and second phases or sequential RCTs respectively |
| A composite outcome in subgroups with or without supplemental oxygen at baseline | Comparative efficacy between treatment arms measuring a composite outcome including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events in the subgroups with or without supplemental oxygen therapy at baseline | During 3 months and during 3 years for first and second phases or sequential RCTs respectively |
| A composite outcome in subgroups of hypercapnia severity at baseline | Comparative efficacy between treatment arms measuring a composite outcome including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events in the subgroups with higher and lower hypercapnia at baseline (above and below of the median PaCO2 measured in mmHg) | During 3 months and During 3 years for first and second phases or sequential RCTs respectively |
| A composite outcome in subgroups of the apnea-hypopnea index severity at baseline | Comparative efficacy between treatment arms measuring a composite outcome including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events in the subgroups with higher and lower apnea-hypopnea index at baseline (above and below of the median apnea-hypopnea index at baseline) | During 3 months and during 3 years for first and second phases or sequential RCTs respectively |
| A composite outcome in subgroups with or without hypertension diagnosis at baseline | Comparative efficacy between treatment arms measuring a composite outcome including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events in the subgroups with or without hypertension diagnosis at baseline | During 3 months and during 3 years for first and second phases or sequential RCTs respectively |
| A composite outcome in subgroups with different home care providers | Comparative efficacy between treatment arms measuring a composite outcome including hospital and ICU admissions, emergency department visits for any cause, and all-cause mortality measured as the number of events in the subgroups with different home care providers (i.e. AirLiquide) | During 3 months and during 3 years for first and second phases or sequential RCTs respectively |
| Validity analysis of EQ 5D-5L test | To perform a validity analysis of EQ 5D-5L test | During 3 months and during 3 years for first and second phases or sequential RCTs respectively |
| 10080847 | Result | Teran-Santos J, Jimenez-Gomez A, Cordero-Guevara J. The association between sleep apnea and the risk of traffic accidents. Cooperative Group Burgos-Santander. N Engl J Med. 1999 Mar 18;340(11):847-51. doi: 10.1056/NEJM199903183401104. |
| 15781100 | Result | Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7. |
| 11502631 | Result | Kessler R, Chaouat A, Schinkewitch P, Faller M, Casel S, Krieger J, Weitzenblum E. The obesity-hypoventilation syndrome revisited: a prospective study of 34 consecutive cases. Chest. 2001 Aug;120(2):369-76. doi: 10.1378/chest.120.2.369. |
| 25915102 | Result | 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. |
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| 29146865 | Result | 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. |
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| 11591566 | Result | Berger KI, Ayappa I, Chatr-Amontri B, Marfatia A, Sorkin IB, Rapoport DM, Goldring RM. Obesity hypoventilation syndrome as a spectrum of respiratory disturbances during sleep. Chest. 2001 Oct;120(4):1231-8. doi: 10.1378/chest.120.4.1231. |
| 27406165 | Result | 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. |
| 30935737 | Result | 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. |
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| 20957853 | Result | Berry RB, Chediak A, Brown LK, Finder J, Gozal D, Iber C, Kushida CA, Morgenthaler T, Rowley JA, Davidson-Ward SL; NPPV Titration Task Force of the American Academy of Sleep Medicine. Best clinical practices for the sleep center adjustment of noninvasive positive pressure ventilation (NPPV) in stable chronic alveolar hypoventilation syndromes. J Clin Sleep Med. 2010 Oct 15;6(5):491-509. |
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| D012140 |
| Respiratory Tract Diseases |
| D007040 | Hypoventilation |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |