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

H

Hospital Universitario Doctor Peset

Status

Unknown

Conditions

Unrecognized Condition

Treatments

Other: CPAP

Study type

Interventional

Funder types

Other

Identifiers

NCT03079466
sleep workgroup

Details and patient eligibility

About

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

Enrollment

96 patients

Sex

All

Ages

70 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

96 participants in 2 patient groups

Treatment CPAP
Active Comparator group
Description:
A group treated with CPAP
Treatment:
Other: CPAP
group without treatment
Sham Comparator group
Treatment:
Other: CPAP

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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