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Effect of CPAP Treatment on the Elderly With Mild to Moderate Sleep Apnea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Silvia Ponce Perez, Hospital Universitario Doctor Peset

Study Description
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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


Condition or disease Intervention/treatment Phase
Unrecognized Condition Other: CPAP Not Applicable

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Treatment CPAP
A group treated with CPAP
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Epworth Sleepiness Scale [ Time Frame: 3 months ]
    Measure of diurnal sleepiness

  2. Quebec Sleep Questionnaire domains [ Time Frame: 3 months ]
    Quality of Life measured in sleep apnea patients


Eligibility Criteria
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Ages Eligible for Study:   70 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Silvia Ponce Perez, Hospital Universitario Doctor Peset:
Sleep apnea
Elderly
CPAP
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases