Neurocognitive Function After Therapy of OSAS

NCT02505620 | Completed

• 1 other identifier: 1
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neurocognitive Function; OSAS

Keywords

Neurocognitive function; OSAS

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Surgical

Surgical correction of OSAS disease

Procedure: Surgical Treatment with multilevel operation

Conservative

Conservative treatment of OSAS disease

Procedure: Treatment of OSAS with CPAP mask

Interventions

Treatment of OSAS with CPAP mask PROCEDURE

Interventional treatment addresses the treatment with a CPAP (continuous positive airway pressure) mask in oder to open patients upper airway obstructive permanently while sleep.

Also known as: CPAP (continuous positive airway pressure) mask

Conservative

Surgical Treatment with multilevel operation PROCEDURE

Surgical treatment addresses a surgical multilevel anti-obstructive operation in order to eliminate upper airway obstruction permanently.

Also known as: Surgical multilevel anti-obstructive operation

Surgical

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

University Hospital Erlangen, Dept. Anaesthesiology

Erlangen, 91054, Germany

Location

MeSH Terms

Interventions

Continuous Positive Airway Pressure; Masks; Surgical Procedures, Operative

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: July 22, 2015
• Study Start: September 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 11, 2020

Record last verified: 2020-12

Locations

DE (1)