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

NCT03079466 | Unknown DMC

• 1 other identifier: sleep workgroup
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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

Conditions

Unrecognized Condition

Keywords

Sleep apnea; Elderly; CPAP

Outcome Measures

Primary Outcomes (2)

• Epworth Sleepiness Scale

  Measure of diurnal sleepiness

  3 months

• Quebec Sleep Questionnaire domains

  Quality of Life measured in sleep apnea patients

  3 months

Study Arms (2)

Treatment CPAP

ACTIVE COMPARATOR

A group treated with CPAP

Other: CPAP

group without treatment

SHAM COMPARATOR

Other: CPAP

Interventions

CPAP OTHER

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.

Treatment CPAP; group without treatment

Eligibility Criteria

• Age: 70 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age equal or greater than 70 years of both sexes
• Patients with sleep study results with AHI ≥ 15 and \< 30

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario Doctor Peset: lead

Related Publications (1)

• Martinez-Garcia MA, Oscullo G, Ponce S, Pastor E, Orosa B, Catalan P, Martinez A, Hernandez L, Muriel A, Chiner E, Vigil L, Carmona C, Mayos M, Garcia-Ortega A, Gomez-Olivas JD, Beauperthuy T, Bekki A, Gozal D. Effect of continuous positive airway pressure in very elderly with moderate-to-severe obstructive sleep apnea pooled results from two multicenter randomized controlled trials. Sleep Med. 2022 Jan;89:71-77. doi: 10.1016/j.sleep.2021.11.009. Epub 2021 Nov 24.

  PMID: 34915264 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: March 14, 2017
• Study Start: March 9, 2017
• Primary Completion: June 10, 2017
• Study Completion: July 15, 2017
• Last Updated: March 14, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share