Sleep Apnea, ObstructivePhase 3NCT02069600
Effect of CPAP Treatment in Elderly: Randomized Clinical Trial
A Phase 3 study testing Continuous Positive Airway Pressure in people with Sleep Apnea, Obstructive, run by Hospital Universitario La Fe at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Continuous Positive Airway Pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2011to Jul 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: OBSTRUCTIVE SLEEP APNEA IN THE ELDERLY. ROLE OF CONTINUOUS POSITIVE AIRWAY PRESSURE TREATMENT. A Randomized Controlled Trial
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.
Read the detailed description
Not needed
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Continuous Positive Airway Pressure
- Keywords
- Elderly, CPAP, clinical trial, obstructive sleep apnea
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway PressureDevice
Also called CPAP device from ResMed CO. Sydney.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Continuous Positive Airway Pressure |
| No intervention | No intervention | No intervention. No placebo is used. Control group without CPAP treatment during three months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Quality of life measure by Quebec Sleep Questionnaire (QSQ). This is an specific sleep questionnaire
Measured: Changes in quality baseline from baseline to 3 months after random
Secondary outcomes (1)
Sleep-related symptoms
Snoring Witnessed apnea Choking Hypersomnolence Nocturia Nightmares
Measured: Changes in sleep-related symptoms from baseline to three months after random
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startJan 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Fe
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Miguel Angel Martinez-Garcia, Hospital Universitario La Fe
- Investigators
- Miguel Angel Martinez Martínez García, MD, PhD, Principal investigator, Hospital La Fe Valwncia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069600
- Sponsor's protocol ID
- RCT-elderly-OSA
- Status last verified
- Feb 2014
- First submitted
- 18 Feb 2014
- Last updated
- 24 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34915264Martinez-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.
PubMed 26022945
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OBSTRUCTIVE SLEEP APNEA IN THE ELDERLY. ROLE OF CONTINUOUS POSITIVE AIRWAY PRESSURE TREATMENT. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02069600
- Acronym / sponsor ID
- RCT-elderly-OSA
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Elderly, CPAP, clinical trial, obstructive sleep apnea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Hospital Universitario La FeUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Jan 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 24 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Positive Airway Pressure | Active comparator | Device: Continuous Positive Airway PressureContinuous 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 |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Positive Airway PressureAlso: CPAP device from ResMed CO. Sydney.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 | Device | Continuous Positive Airway Pressure |
Primary outcome
Quality of life
Time frame: Changes in quality baseline from baseline to 3 months after random
Quality of life measure by Quebec Sleep Questionnaire (QSQ). This is an specific sleep questionnaire
1 secondary outcome
Sleep-related symptoms
Time frame: Changes in sleep-related symptoms from baseline to three months after random
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2014.
- Derived from this study: PubMed 34915264Martinez-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.
- Derived from this study: PubMed 26022945Martinez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel Angel Martinez Martínez García, MD, PhD principal investigator
Hospital La Fe Valwncia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Continuous Positive Airway Pressure in people with Sleep Apnea, Obstructive, run by Hospital Universitario La Fe at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: Changes in quality baseline from baseline to 3 months after random). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02069600, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2014.