Study of the Reversibility of Vigilance Dysfunction at 6 Months of Continuous Positive Airways Pressure (CPAP) in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS) (VISA)

Study of the Reversibility of Vigilance Dysfunction at 6 Months of Continuous Positive Airways Pressure (CPAP) in Patients With Obstructive Sleep

It is a monocentric prospective pilot study in Poitiers University Hospital, specifically analyzing the vigilance disorders in the Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and their reversibility after 6 months of Continuous positive airways pressure (CPAP).

All subjects were administered a test of vigilance (Test of Attentional Performance) both before and after the 6 months of CPAP.

The main objective is the study of the reversibility of alertness disorders on the number of omissions in the subtest visual vigilance of the TAP ( (Test of Attentional Performance) at 6 months of CPAP in the OSAHS in patients with a memory complaint.

Study Overview

• Status: Completed
• Conditions: Vigilance Dysfunction
• Intervention / Treatment: Diagnostic test: tests of attentional performance

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Poitiers, France, 86000
    • service de neurologie CHU DE POITIERS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aged 20-70 years
• Memory disorders without memory problems in episodic memory

• Presence of polysomnography of a obstructive sleep apnea/hypopnea syndrome (OSAHS) requiring Continuous positive airways pressure

  • Moderate OSAHS (Apnea Hypopnea Index ≥ 15 / hour with arousals ≥ 10)
  • Severe OSAHS (Apnea Hypopnea Index ≥ 30 / h)

Exclusion Criteria:

• Age <20 years or ≥ 70 years
• Neurodegenerative disease (Alzheimer's disease, Parkinson's disease)
• Dysthyroidism
• Severe depression, schizophrenia, bipolar disorder
• Treatment with an effect on cognition: hypnotics, sedative
• Chronic Obstructive Pulmonary Disease
• Chronic alcoholism, other addictions
• Contraindications to Magnetic Resonance Imaging
• Refusal of equipment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tests of attentional performance	Diagnostic test: tests of attentional performance; tests of attentional performance before and after 6 months of continuous positive airways pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study of the reversibility of vigilance disorders on the number of omissions in the subtest visual vigilance of the TAP	Reversibility of vigilance disorders on the number of omissions in the subtest visual vigilance of the TAP	After 6 months of continuous positive airways pressure in the OSAHS patient

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2017
• Primary Completion (Actual): February 9, 2021
• Study Completion (Actual): February 9, 2021

Study Registration Dates

• First Submitted: November 13, 2017
• First Submitted That Met QC Criteria: November 13, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): November 29, 2021
• Last Update Submitted That Met QC Criteria: November 26, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: VISA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No