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Completed

NCT Number: NCT03344263

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)

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.

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Key information

Conditions

Vigilance Dysfunction

Age range

20 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

service de neurologie CHU DE POITIERS

Poitiers, 86000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tests of attentional performance

Diagnostic Test

tests of attentional performance before and after 6 months of continuous positive airways pressure

Primary outcomes

  1. Study of the reversibility of vigilance disorders on the number of omissions in the subtest visual vigilance of the TAP

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

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

Acronym: VISA

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Nov 17, 2017
Registry last updated
Nov 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.