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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
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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