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

NCT ID: NCT03079466

Last Updated: 2017-03-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-09
• Study Completion Date: 2017-07-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment CPAP

A group treated with CPAP

Group Type: ACTIVE_COMPARATOR

CPAP

Intervention Type: 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.

group without treatment

Group Type: SHAM_COMPARATOR

CPAP

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Doctor Peset

OTHER

Sponsor Role: lead

Responsible Party

Silvia Ponce Perez

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 34915264 (View on PubMed)

Other Identifiers

sleep workgroup

Identifier Type: -

Identifier Source: org_study_id