Clinical trial NCT02069600: Effect of CPAP Treatment in Elderly: Randomized Clinical Trial
Official title: OBSTRUCTIVE SLEEP APNEA IN THE ELDERLY. ROLE OF CONTINUOUS POSITIVE AIRWAY PRESSURE TREATMENT. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sleep Apnea, Obstructive
Keywords: Elderly
CPAP
clinical trial
obstructive sleep apnea
Lead sponsor: Hospital Universitario La Fe
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2014-02-24
Enrollment: 224
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Not needed

Eligibility criteria: Inclusion Criteria:

* Patients were initially eligible for participation in the study if they were aged at least 70 years, had an apnea-hypopnea index (AHI) ≥30 and had signed the informed consent to participate

Exclusion Criteria:

* Current use of CPAP treatment, central sleep apnea (defined as at least 50% of respiratory events having a pattern of apnea or hypopnea without respiratory effort), respiratory failure (defined as diurnal oxygen saturation below 90%), severe heart failure (NYHA III-IV), a cardiovascular event in the month prior to the inclusion in the study or disabling hypersomnia requiring urgent treatment (defined as an Epworth Sleepiness Scale ≥ 18).

Primary outcomes:
measure: Quality of life
timeFrame: Changes in quality baseline from baseline to 3 months after random
Secondary outcomes:
measure: Sleep-related symptoms
timeFrame: Changes in sleep-related symptoms from baseline to three months after random
Other outcomes:
measure: Neurocognitive tests
timeFrame: Changes in neurocognitive tests from baseline to three months after random
measure: Office Blood pressure measurements
timeFrame: Changes in blood pressure levels from baseline to three months after random
Locations:
city: Valencia
country: Spain
facility: Hospital Universitario La Fe Valwncia
Study officials:
affiliation: Hospital La Fe Valwncia
name: Miguel Angel Martinez Martínez García, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.