Neurocognitive Function After Therapy of OSAS (203_14_B)

Neurocognitive Function After Surgical and Conservative Therapy in OSAS Patients: a Randomized Control Trial

Obstructive Sleep Apnea Syndrome (OSAS) is characterized by repeated episodes of airway obstruction while sleeping. Upper airway obstruction while sleeping leads to a dramatic decrease in oxygen saturation and to hypoxemia finally, in which consequence the patient rapidly awake. Clinical signs are sleepiness and functional cognitive deficits. The Gold standard therapy is "continuous positive airway pressure" ventilation during sleep. However, the success depends strongly to the patient´s compliance. Surgical treatment is an alternative option, which could be considered if clinical success failed. A comparison of the cognitive function of both therapies is not yet analyzed. The study addresses the question which of this treatment options is favorable regarding cognitive function and outcome.

Study Overview

• Status: Completed
• Conditions: Neurocognitive Function; OSAS
• Intervention / Treatment: Procedure: Surgical Treatment with multilevel operation; Procedure: Treatment of OSAS with CPAP mask

Detailed Description

Obstructive Sleep Apnea Syndrome (OSAS) is characterized by repeated episodes of airway obstruction while sleeping. The "Apnea-hypopnea index" (AHI) defined as events per hour, gives information about the severity of the disease. The American Academy of Sleep Medicine Task Force" defined that more than 5 episodes per hour is strongly suspect for an OSAS disease. Upper airway obstruction while sleeping leads to a dramatic decrease in oxygen saturation and to hypoxemia finally, in which consequence the patient rapidly awake. The prevalence rise with age and about 20% of the population is suspect to a sleep disorder. However about 1-5% of male and about 0,5-2% of female aged adults are affected. Main reason is obesity. Clinical signs are sleepiness and functional cognitive deficits. The Gold standard therapy is "continuous positive airway pressure" ventilation during sleep. However, the success depends strongly to the patient´s compliance. Surgical treatment is an alternative option, which could be considered if clinical success failed. It is notable that the long-term mortality is comparable in both medical treatment options. However, a comparison of the cognitive function of both therapies is not yet analyzed. The study addresses the question which of this treatment options is favorable regarding cognitive function and outcome.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Germany
  • Erlangen, Germany, 91054
    • University Hospital Erlangen, Dept. Anaesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients recruted at the University Hospital Erlangen prior surgery or conventional treatment.

Description

Inclusion Criteria:

* Patients within 30 to 70 years of age both gender.

Exclusion Criteria:

• Patients under 30 years of age or older than 70 years of age.
• Preexisting neurological, neuropsychological deficits or diseases, e.g. cerebral insult or epilepsy.
• Preexisting neurological, neuropsychological medication.
• Preexisting neuromuscular diseases.
• Alcohol - and drug abuse.
• Postoperative complications, pain and time shifts within the test protocol.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgical; Surgical correction of OSAS disease	Procedure: Surgical Treatment with multilevel operation; Surgical treatment addresses a surgical multilevel anti-obstructive operation in order to eliminate upper airway obstruction permanently.; Other Names: Surgical multilevel anti-obstructive operation
Conservative; Conservative treatment of OSAS disease	Procedure: Treatment of OSAS with CPAP mask; Interventional treatment addresses the treatment with a CPAP (continuous positive airway pressure) mask in oder to open patients upper airway obstructive permanently while sleep.; Other Names: CPAP (continuous positive airway pressure) mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurocognitive function	Using different tests addressing a various quality of neurocognitive function (attention, memory, perceptual and processing speed, alertness and executive function) participants score test appropriate values. Comparing test values separately allows to distinguish between prior - and post - operative and prior and post - interventional status. Moreover it allows to discriminate achieved test results between both groups and calculate statistical differences. Favorable test results lead to a potential better neurocognitive function outcome and enable to assess neurocognitive function in the light of operation or interventional consequence.	4 months

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: June 9, 2015
• First Submitted That Met QC Criteria: July 20, 2015
• First Posted (Estimate): July 22, 2015

Study Record Updates

• Last Update Posted (Actual): December 11, 2020
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Neurocognitive function; OSAS
• Other Study ID Numbers: 1