Protocol Memory Deficit in Patients With Obstructive Sleep Apnea Syndrome

Memory Deficit Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00464659
• Other study ID #: 0629
• Status: Completed
• Phase: N/A
• First received: April 20, 2007
• Last updated: December 29, 2015
• Start date: April 2007
• Est. completion date: June 2013

Study information

• Verified date: December 2015
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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".

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Memory Deficit
• Memory Disorders
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
France	Laboratoire EFCR-Functional Cardio-Respiratory Exploration Laboratory	Grenoble	Isere

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (4)

Beebe DW, Gozal D. Obstructive sleep apnea and the prefrontal cortex: towards a comprehensive model linking nocturnal upper airway obstruction to daytime cognitive and behavioral deficits. J Sleep Res. 2002 Mar;11(1):1-16. Review. — View Citation

Engleman HM, Douglas NJ. Sleep. 4: Sleepiness, cognitive function, and quality of life in obstructive sleep apnoea/hypopnoea syndrome. Thorax. 2004 Jul;59(7):618-22. Review. — View Citation

Farré R, Hernández L, Montserrat JM, Rotger M, Ballester E, Navajas D. Sham continuous positive airway pressure for placebo-controlled studies in sleep apnoea. Lancet. 1999 Apr 3;353(9159):1154. — View Citation

Naëgelé B, Launois SH, Mazza S, Feuerstein C, Pépin JL, Lévy P. Which memory processes are affected in patients with obstructive sleep apnea? An evaluation of 3 types of memory. Sleep. 2006 Apr;29(4):533-44. — View Citation