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)

Vigilance Dysfunction Clinical Trial

— VISA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03344263
• Other study ID #: VISA
• Status: Completed
• Phase: N/A
• Start date: November 17, 2017
• Est. completion date: February 9, 2021

Study information

• Verified date: November 2021
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 9, 2021
• Est. primary completion date: February 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Vigilance Dysfunction

Intervention

Diagnostic Test:
• tests of attentional performance
tests of attentional performance before and after 6 months of continuous positive airways pressure

Locations

Country	Name	City	State
France	service de neurologie CHU DE POITIERS	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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