Protocol Memory Deficit in Patients With Obstructive Sleep Apnea Syndrome

Comparison of the Evolution of Memory Deficit in Patients With Sleep Apnea Obstructive Syndrome (SAOS) Before and After "Effective" Versus Sham Treatment by Positive Pression Continues (PPC)

Sponsors

Lead Sponsor: University Hospital, Grenoble

Source 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).

Overall Status Completed
Start Date April 2007
Completion Date June 2013
Primary Completion Date June 2013
Phase N/A
Study Type Interventional
Enrollment 40
Condition
Intervention

Intervention Type: Device

Intervention Name: Effective CPAP

Description: Auto-titrating CPAP machines (Remstar Auto; Philips Respironics, Murrysville, PA) provided by a home care company (Bastide Medical, France). Pressure was set between 6 and 14 cm of water

Arm Group Label: Effective CPAP treatment

Intervention Type: Device

Intervention Name: Sham CPAP

Description: Similar CPAP machine delivering a 4 cm of water pressure that was too low to suppress sleep respiratory events.

Arm Group Label: Sham CPAP treatment

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jean-Louis JP Pépin, ProfessorPhD Principal Investigator University Hospital, Grenoble
Location
Facility: Laboratoire EFCR-Functional Cardio-Respiratory Exploration Laboratory
Location Countries

France

Verification Date

December 2015

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Effective CPAP treatment

Type: Experimental

Description: Effective Continuous Positive Airway Pressure treatment (CPAP) applied for 6 weeks

Label: Sham CPAP treatment

Type: Sham Comparator

Description: Ineffective Continuous Positive Airway Pressure treatment (sham CPAP) applied for 6 weeks

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov