Protocol Memory Deficit in Patients With Obstructive Sleep Apnea Syndrome

Not Applicable

Completed

• Conditions: Memory Deficit
• Interventions: Device: Sham CPAP; Device: Effective CPAP

• Registration Number: NCT00464659
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

The main objective of this study is to evaluate the evolution of memory deficit (verbal episodic memory, procedural memory, working memory, short-term memory) in Sleep Apnea Obstructive Syndrome (SAOS) patients after treatment by Continuous Positive Airway Pressure treatment (CPAP). For thus, we will compare memory tests in two separate groups of SAOS patients with "effective " versus "ineffective" ( or sham) CPAP, before and 6 weeks after the beginning of the treatment. Thus we will assess the evolution of memory deficit, the effectiveness of the treatment on the evolution of memory deficit before and 6 weeks after the beginning of the treatment by "effective " versus "ineffective" CPAP.

We feel the results of the tests of memory will show greater memory disorders in patients with SAOS before beginning the treatment rather than six weeks afterwards. Thus we hypothesise that, after the treatment by "effective" CPAP, the patients with SAOS will have greater improvement of their memory disorders than those treated by "sham CPAP".

Detailed Description

We want to assess the evolution, before and 6 weeks after the beginning of the treatment, of the significant differences of the performances of the various memory tests evaluating several forms of memory (episodic memory, working memory, short-term memory and procedural memory) according to the treatment for patients with SAOS (effective versus sham).

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-04-20
• Study First Submitted QC: 2007-04-20
• Study First Posted: 2007-04-23
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-29
• Last Update Posted: 2015-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Major patients,
• agreeing,
• diagnosed suffering from the SAOS,
• regulation by the specialist in a treatment by CPAP,
• patients do not begin the treatment
• affiliated to the social security,
• fluent in French.

Exclusion Criteria

• Patients presenting severe depressive disorders (HADS score>19),
• intellectual deterioration (MMS< 28),
• a functional failure of the dominant arm upper limb inhibiting realization of graphic tasks,
• an associated oxygen treatment,
• suffering from cancer,
• cerebro-vascular accident,
• pregnant or nursing women,
• adult under supervision or trusteeship,
• patients already included in another research protocol or in period of exclusion,
• antidepressant and anxiolytic treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham CPAP treatment	Sham CPAP	Ineffective Continuous Positive Airway Pressure treatment (sham CPAP) applied for 6 weeks
Effective CPAP treatment	Effective CPAP	Effective Continuous Positive Airway Pressure treatment (CPAP) applied for 6 weeks

Trial Locations

Locations (1)

Laboratoire EFCR-Functional Cardio-Respiratory Exploration Laboratory; 🇫🇷 Grenoble, Isere, France