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

March 13, 2017 updated by: Silvia Ponce Perez, Hospital Universitario Doctor Peset

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years to 100 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epworth Sleepiness Scale
Time Frame: 3 months
Measure of diurnal sleepiness
3 months
Quebec Sleep Questionnaire domains
Time Frame: 3 months
Quality of Life measured in sleep apnea patients
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Doctor Peset

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2017

Primary Completion (Anticipated)

June 10, 2017

Study Completion (Anticipated)

July 15, 2017

Study Registration Dates

First Submitted

March 9, 2017

First Submitted That Met QC Criteria

March 13, 2017

First Posted (Actual)

March 14, 2017

Study Record Updates

Last Update Posted (Actual)

March 14, 2017

Last Update Submitted That Met QC Criteria

March 13, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sleep workgroup

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Unrecognized Condition

Clinical Trials on CPAP

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe