Effect of CPAP Treatment in Elderly: Randomized Clinical Trial
Primary Purpose
Sleep Apnea, Obstructive
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Continuous Positive Airway Pressure
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Elderly, CPAP, clinical trial, obstructive sleep apnea
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).
Sites / Locations
- Hospital Universitario La Fe Valwncia
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Continuous Positive Airway Pressure
No intervention
Arm Description
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 placebo is used. Control group without CPAP treatment during three months
Outcomes
Primary Outcome Measures
Quality of life
Quality of life measure by Quebec Sleep Questionnaire (QSQ). This is an specific sleep questionnaire
Secondary Outcome Measures
Sleep-related symptoms
Snoring Witnessed apnea Choking Hypersomnolence Nocturia Nightmares
Full Information
NCT ID
NCT02069600
First Posted
February 18, 2014
Last Updated
February 20, 2014
Sponsor
Hospital Universitario La Fe
Collaborators
Instituto de Salud Carlos III
1. Study Identification
Unique Protocol Identification Number
NCT02069600
Brief Title
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
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario La Fe
Collaborators
Instituto de Salud Carlos III
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
Elderly, CPAP, clinical trial, obstructive sleep apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
224 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continuous Positive Airway Pressure
Arm Type
Active Comparator
Arm Description
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
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No intervention. No placebo is used. Control group without CPAP treatment during three months
Intervention Type
Device
Intervention Name(s)
Continuous Positive Airway Pressure
Other Intervention Name(s)
CPAP device from ResMed CO. Sydney.
Intervention Description
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
Primary Outcome Measure Information:
Title
Quality of life
Description
Quality of life measure by Quebec Sleep Questionnaire (QSQ). This is an specific sleep questionnaire
Time Frame
Changes in quality baseline from baseline to 3 months after random
Secondary Outcome Measure Information:
Title
Sleep-related symptoms
Description
Snoring Witnessed apnea Choking Hypersomnolence Nocturia Nightmares
Time Frame
Changes in sleep-related symptoms from baseline to three months after random
Other Pre-specified Outcome Measures:
Title
Neurocognitive tests
Description
Trail-Making-Test A Trail-Making-Test B Digital Symbol Test Digit Span Test Hospital Depression and Anxiety test Epworth test
Time Frame
Changes in neurocognitive tests from baseline to three months after random
Title
Office Blood pressure measurements
Description
3 office Systolic blood pressure and diastolic blood pressure
Time Frame
Changes in blood pressure levels from baseline to three months after random
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel Angel Martinez Martínez García, MD, PhD
Organizational Affiliation
Hospital La Fe Valwncia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario La Fe Valwncia
City
Valencia
ZIP/Postal Code
461015
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
34915264
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.
Results Reference
derived
PubMed Identifier
26022945
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.
Results Reference
derived
Learn more about this trial
Effect of CPAP Treatment in Elderly: Randomized Clinical Trial
We'll reach out to this number within 24 hrs