VISA: 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)

• Sponsor: Poitiers University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03344263
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Arm: 1
• Actual Duration (Months): 38.8
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Vigilance Dysfunction	Diagnostic Test: tests of attentional performance	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Study of the Reversibility of Vigilance Dysfunction at 6 Months of Continuous Positive Airways Pressure (CPAP) in Patients With Obstructive Sleep
• Actual Study Start Date: Nov 17, 2017
• Actual Primary Completion Date: Feb 9, 2021
• Actual Study Completion Date: Feb 9, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Study of the 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]

   Reversibility of vigilance disorders on the number of omissions in the subtest visual vigilance of the TAP

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 69 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	service de neurologie CHU DE POITIERS	Poitiers		France	86000

Sponsors and Collaborators

• Poitiers University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Poitiers University Hospital
• ClinicalTrials.gov Identifier: NCT03344263
• Other Study ID Numbers: VISA
• First Posted: Nov 17, 2017
• Last Update Posted: Nov 29, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 29, 2021