Protocol Memory Deficit in Patients With Obstructive Sleep Apnea Syndrome

NCT00464659 | Completed DMC

• 1 other identifier: 0629
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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".

Conditions

Memory Deficit

Keywords

Sleep apnea obstructive syndrome (SAOS); memory deficit; Continuous Positive Airway Pression (CPAP); Sham CPAP

Study Arms (2)

Effective CPAP treatment

EXPERIMENTAL

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

Device: Effective CPAP

Sham CPAP treatment

SHAM COMPARATOR

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

Device: Sham CPAP

Interventions

Effective CPAP DEVICE

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

Effective CPAP treatment

Sham CPAP DEVICE

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

Sham CPAP treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• antidepressant and anxiolytic treatment.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Laboratoire EFCR-Functional Cardio-Respiratory Exploration Laboratory

Grenoble, Isere, France

Location

Related Publications (6)

• 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. doi: 10.1046/j.1365-2869.2002.00289.x.

  PMID: 11869421 BACKGROUND

• 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. doi: 10.1136/thx.2003.015867.

  PMID: 15223874 BACKGROUND

• Farre R, Hernandez 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. doi: 10.1016/S0140-6736(99)01056-9. No abstract available.

  PMID: 10209985 BACKGROUND

• Naegele B, Launois SH, Mazza S, Feuerstein C, Pepin JL, Levy 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. doi: 10.1093/sleep/29.4.533.

  PMID: 16676787 BACKGROUND

• Joyeux-Faure M, Naegele B, Pepin JL, Tamisier R, Levy P, Launois SH. Continuous positive airway pressure treatment impact on memory processes in obstructive sleep apnea patients: a randomized sham-controlled trial. Sleep Med. 2016 Aug;24:44-50. doi: 10.1016/j.sleep.2016.06.023. Epub 2016 Aug 23.

  PMID: 27810185 DERIVED

• Jullian-Desayes I, Tamisier R, Zarski JP, Aron-Wisnewsky J, Launois-Rollinat SH, Trocme C, Levy P, Joyeux-Faure M, Pepin JL. Impact of effective versus sham continuous positive airway pressure on liver injury in obstructive sleep apnoea: Data from randomized trials. Respirology. 2016 Feb;21(2):378-85. doi: 10.1111/resp.12672. Epub 2015 Nov 16.

  PMID: 26567858 DERIVED

MeSH Terms

Conditions

Memory Disorders; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Officials

• Jean-Louis JP Pépin, ProfessorPhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2007
• First Posted: April 23, 2007
• Study Start: April 1, 2007
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 30, 2015

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)