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

Unrecognized Condition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03079466
• Other study ID #: sleep workgroup
• Status: Active, not recruiting
• Phase: N/A
• First received: March 9, 2017
• Last updated: March 13, 2017
• Start date: March 9, 2017
• Est. completion date: July 15, 2017

Study information

• Verified date: March 2017
• Source: Hospital Universitario Doctor Peset
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 96
• Est. completion date: July 15, 2017
• Est. primary completion date: June 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Unrecognized Condition

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Doctor Peset

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epworth Sleepiness Scale	Measure of diurnal sleepiness	3 months
Primary	Quebec Sleep Questionnaire domains	Quality of Life measured in sleep apnea patients	3 months