Unrecognized ConditionNCT03079466
Effect of CPAP Treatment on the Elderly With Mild to Moderate Sleep Apnea
A study testing CPAP in people with Unrecognized Condition, run by Hospital Universitario Doctor Peset.
Trial summary
Objective: To analyze the impact of CPAP treatment on cognitive, clinical and quality of life domains in patients over 70 years of age with mild-to-moderate OSA Primary Outcome: Epworth scale and QSQ domains Secondary Outcomes: Neurocognitive variables and CPAP adherence Read more about this study
- Who is it for?
- Ages 70 to 100 years
- Conditions the study is for
- Unrecognized Condition
- What is being tested?
- CPAP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 9 Mar 2017to 15 Jul 2017
- Phase
- Interventional
- 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 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age equal or greater than 70 years of both sexes
- Patients with sleep study results with AHI ≥ 15 and < 30
Who cannot join
- Alternative diagnoses of other non-respiratory sleep disorders that are also cause of pathological somnolence (eg, sdr restless legs, narcolepsy, etc.)
- Don't sign informed consent
- Acute or chronic respiratory insufficiency requiring home oxygen therapy
- Patients with Obesity Hypoventilation Syndrome
- Diagnosis of neuro-psychiatric diseases with the exception of anxiety - depression or diagnosis of dementia.
- Diseases of any origin in the acute phase
Show all 11Show fewer
- Heart failure or recent stroke (less than 3 months).
- Central SAHS (more than 50% of the registry with central apneas or Cheyne-Stokes breathing)
- Pre-treatment with CPAP
- Inability to perform the diagnostic study of sleep due to the patient's condition
- Hipersomniaincapacitante (Epworth≥18) with no known or most likely cause related to SAHS
About this study
Objective: To analyze the impact of CPAP treatment on cognitive, clinical and quality of life domains in patients over 70 years of age with mild-to-moderate OSA
Primary Outcome: Epworth scale and QSQ domains
Secondary Outcomes: Neurocognitive variables and CPAP adherence
- Conditions
- Unrecognized Condition
- Being tested
- CPAP
- Keywords
- Sleep apnea, Elderly, CPAP
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPOther
This is a randomized study where patients are included consecutively under a randomization order that will be given to the investigators. Patients will continue to be treated with CPAP and other treatment with no CPAP for a duration of 3 months and with intention-to-treat analysis And by protocol.
| Study group | Role | What they receive |
|---|---|---|
| Treatment CPAP | Active comparator | A group treated with CPAP Receives: Other: CPAP |
| group without treatment | Sham comparator | Not described Receives: Other: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epworth Sleepiness Scale
Measure of diurnal sleepiness
Measured: 3 months
Quebec Sleep Questionnaire domains
Quality of Life measured in sleep apnea patients
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start9 Mar 2017
- Primary completion10 Jun 2017 (estimated)
- Study completion15 Jul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unrecognized ConditionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Doctor Peset
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Ponce Perez, Hospital Universitario Doctor Peset
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079466
- Sponsor's protocol ID
- sleep workgroup
- Status last verified
- Mar 2017
- First submitted
- 9 Mar 2017
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 34915264
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of CPAP Treatment on the Elderly With Mild to Moderate Sleep Apnea
- ClinicalTrials.gov ID
- NCT03079466
- Acronym / sponsor ID
- sleep workgroup
- Conditions
- Unrecognized Condition
- Keywords
- Sleep apnea, Elderly, CPAP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Hospital Universitario Doctor PesetUniversity, hospital or other
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 10 Jun 2017 (estimated)
- Study completion
- 15 Jul 2017 (estimated)
- First posted
- 14 Mar 2017 (actual)
- 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.
Objective: To analyze the impact of CPAP treatment on cognitive, clinical and quality of life domains in patients over 70 years of age with mild-to-moderate OSA
Primary Outcome: Epworth scale and QSQ domains
Secondary Outcomes: Neurocognitive variables and CPAP adherence
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Treatment CPAP | Active comparator | Other: CPAPA group treated with CPAP |
| group without treatment | Sham comparator | Other: CPAP |
Who may qualify
- Ages
- 70 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age equal or greater than 70 years of both sexes
- Patients with sleep study results with AHI ≥ 15 and < 30
Key exclusion criteria (11 listed)
- Alternative diagnoses of other non-respiratory sleep disorders that are also cause of pathological somnolence (eg, sdr restless legs, narcolepsy, etc.)
- Don't sign informed consent
- Acute or chronic respiratory insufficiency requiring home oxygen therapy
- Patients with Obesity Hypoventilation Syndrome
- Diagnosis of neuro-psychiatric diseases with the exception of anxiety - depression or diagnosis of dementia.
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 |
|---|---|---|
| CPAPThis is a randomized study where patients are included consecutively under a randomization order that will be given to the investigators. Patients will continue to be treated with CPAP and other treatment with no CPAP for a duration of 3 months and with intention-to-treat analysis And by protocol. | Other | Treatment CPAP, group without treatment |
Primary outcome
Epworth Sleepiness Scale
Time frame: 3 months
Measure of diurnal sleepiness
Quebec Sleep Questionnaire domains
Time frame: 3 months
Quality of Life measured in sleep apnea patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- 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.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP in people with Unrecognized Condition, run by Hospital Universitario Doctor Peset.
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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
Epworth Sleepiness Scale (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT03079466, which also lists 1 linked publication.
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 14 Mar 2017.