Back to resultsEffect of CPAP Treatment on the Elderly With Mild to Moderate Sleep Apnea
Primary Purpose
Unrecognized Condition
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CPAP
Sponsored by
About this trial
This is an interventional treatment trial for Unrecognized Condition focused on measuring Sleep apnea, Elderly, CPAP
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Treatment CPAP
group without treatment
Arm Description
A group treated with CPAP
Outcomes
Primary Outcome Measures
Epworth Sleepiness Scale
Measure of diurnal sleepiness
Quebec Sleep Questionnaire domains
Quality of Life measured in sleep apnea patients
Secondary Outcome Measures
Full Information
NCT ID
NCT03079466
First Posted
March 9, 2017
Last Updated
March 13, 2017
Sponsor
Hospital Universitario Doctor Peset
1. Study Identification
Unique Protocol Identification Number
NCT03079466
Brief Title
Effect of CPAP Treatment on the Elderly With Mild to Moderate Sleep Apnea
Official Title
Effect of CPAP Treatment on the Elderly With Mild to Moderate Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 9, 2017 (Actual)
Primary Completion Date
June 10, 2017 (Anticipated)
Study Completion Date
July 15, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Doctor Peset
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unrecognized Condition
Keywords
Sleep apnea, Elderly, CPAP
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment CPAP
Arm Type
Active Comparator
Arm Description
A group treated with CPAP
Arm Title
group without treatment
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
CPAP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Epworth Sleepiness Scale
Description
Measure of diurnal sleepiness
Time Frame
3 months
Title
Quebec Sleep Questionnaire domains
Description
Quality of Life measured in sleep apnea patients
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
Yes
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
Learn more about this trial
Effect of CPAP Treatment on the Elderly With Mild to Moderate Sleep Apnea
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