Effect of CPAP Treatment in Elderly: Randomized Clinical Trial

NCT02069600 | Completed Phase 3 DMC

• 1 other identifier: RCT-elderly-OSA
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive

Keywords

Elderly; CPAP; clinical trial; obstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Sleep-related symptoms

  Changes in sleep-related symptoms from baseline to three months after random

Other Outcomes (2)

• Neurocognitive tests

  Changes in neurocognitive tests from baseline to three months after random

• Office Blood pressure measurements

  Changes in blood pressure levels from baseline to three months after random

Study Arms (2)

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

Device: Continuous Positive Airway Pressure

No intervention

NO INTERVENTION

No intervention. No placebo is used. Control group without CPAP treatment during three months

Interventions

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

Also known as: CPAP device from ResMed CO. Sydney.

Continuous Positive Airway Pressure

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario La Fe: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Hospital Universitario La Fe Valwncia

Valencia, Valencia, 461015, Spain

Location

Related Publications (2)

• 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.

  PMID: 34915264 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.

  PMID: 26022945 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Miguel Angel Martinez Martínez García, MD, PhD

  Hospital La Fe Valwncia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: February 24, 2014
• Study Start: January 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: February 24, 2014

Record last verified: 2014-02

Locations

ES (1)