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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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Rationale: Almost all the information the investigators have about the effect of continuous positive airway pressure (CPAP) in patients with obstructive sleep apnea (OSA) comes from randomized clinical trials including only middle-aged patients. Little is know, however, about the effect of CPAP in elderly people with OSA. Objective: To assess the effect of CPAP treatment in elderly patients with severe OSA on clinical, quality-of-life and neurocognitive spheres. Methods and Measurements: Open-label, randomized, multicenter clinical trial of parallel groups with blinded end-point design conducted in 12 Spanish teaching hospitals on a consecutive clinical cohort of elderly (≥ 70 years) patients with confirmed severe OSA (IAH≥ 30) receiving CPAP or no therapy while maintaining their usual control for three months. CPAP titration was performed by an auto CPAP device. A good adherence was set as at least 4 hours/day of CPAP use. Primary endpoint was the measurement of quality of life by the Quebec Sleep questionnaire, which includes diurnal and nocturnal symptoms, hypersomnolence, and social and emotional dimensions. Secondary endpoints include different sleep-related symptoms, presence of anxiety or depression, office blood pressure figures and some neurocognitive tests. Patients were invited to a clinical visit on three occasions to quantify the adherence to CPAP. Intention-to-treat analysis was performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Positive Airway Pressure | Active Comparator | Continuous Positive Airway Pressure is a device that apply a positive pressure in the airway to avoid its collapse during sleep during three months in this study |
|
| No intervention | No Intervention | No intervention. No placebo is used. Control group without CPAP treatment during three months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Positive Airway Pressure | Device | CPAP applies a positive pressure into the airway to avoid its collapse during sleep. The pressure used in each patient is calculate by an auto CPAP device during 3 months. This device calculate the pressure that avoid 95% of sleep-disordered breathing |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Quality of life measure by Quebec Sleep Questionnaire (QSQ). This is an specific sleep questionnaire | Changes in quality baseline from baseline to 3 months after random |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep-related symptoms | Snoring Witnessed apnea Choking Hypersomnolence Nocturia Nightmares | Changes in sleep-related symptoms from baseline to three months after random |
| Measure | Description | Time Frame |
|---|---|---|
| Neurocognitive tests | Trail-Making-Test A Trail-Making-Test B Digital Symbol Test Digit Span Test Hospital Depression and Anxiety test Epworth test | Changes in neurocognitive tests from baseline to three months after random |
| Office Blood pressure measurements |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miguel Angel Martinez MartÃnez GarcÃa, MD, PhD | Hospital La Fe Valwncia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La Fe Valwncia | Valencia | Valencia | 461015 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34915264 | Derived | Martinez-Garcia MA, Oscullo G, Ponce S, Pastor E, Orosa B, Catalan P, Martinez A, Hernandez L, Muriel A, Chiner E, Vigil L, Carmona C, Mayos M, Garcia-Ortega A, Gomez-Olivas JD, Beauperthuy T, Bekki A, Gozal D. Effect of continuous positive airway pressure in very elderly with moderate-to-severe obstructive sleep apnea pooled results from two multicenter randomized controlled trials. Sleep Med. 2022 Jan;89:71-77. doi: 10.1016/j.sleep.2021.11.009. Epub 2021 Nov 24. | |
| 26022945 |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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|
|
3 office Systolic blood pressure and diastolic blood pressure |
| Changes in blood pressure levels from baseline to three months after random |
| Derived |
| Martinez-Garcia MA, Chiner E, Hernandez L, Cortes JP, Catalan P, Ponce S, Diaz JR, Pastor E, Vigil L, Carmona C, Montserrat JM, Aizpuru F, Lloberes P, Mayos M, Selma MJ, Cifuentes JF, Munoz A; Spanish Sleep Network. Obstructive sleep apnoea in the elderly: role of continuous positive airway pressure treatment. Eur Respir J. 2015 Jul;46(1):142-51. doi: 10.1183/09031936.00064214. Epub 2015 May 28. |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012138 |
| Respiratory Therapy |