Effect of CPAP Treatment on the Elderly With Mild to Moderate Sleep Apnea
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ClinicalTrials.gov Identifier: NCT03079466 |
Recruitment Status : Unknown
Verified March 2017 by Silvia Ponce Perez, Hospital Universitario Doctor Peset.
Recruitment status was: Active, not recruiting
First Posted : March 14, 2017
Last Update Posted : March 14, 2017
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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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Unrecognized Condition | Other: CPAP | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 96 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomized clinical trial |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Effect of CPAP Treatment on the Elderly With Mild to Moderate Sleep Apnea |
Actual Study Start Date : | March 9, 2017 |
Estimated Primary Completion Date : | June 10, 2017 |
Estimated Study Completion Date : | July 15, 2017 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Treatment CPAP
A group treated with CPAP
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Other: CPAP
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. |
Sham Comparator: group without treatment |
Other: CPAP
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. |
- 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

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Ages Eligible for Study: | 70 Years to 100 Years (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age equal or greater than 70 years of both sexes
- Patients with sleep study results with AHI ≥ 15 and < 30
Exclusion Criteria:
- 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
- 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
Responsible Party: | Silvia Ponce Perez, Doctor, Hospital Universitario Doctor Peset |
ClinicalTrials.gov Identifier: | NCT03079466 |
Other Study ID Numbers: |
sleep workgroup |
First Posted: | March 14, 2017 Key Record Dates |
Last Update Posted: | March 14, 2017 |
Last Verified: | March 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Sleep apnea Elderly CPAP |
Sleep Apnea Syndromes Apnea Respiration Disorders Respiratory Tract Diseases |
Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |