Skip to main content
OpenTrials
Completed

NCT Number: NCT02505620

Neurocognitive Function After Therapy of OSAS

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Erlangen, Dept. Anaesthesiology

Erlangen, 91054, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: CPAP (continuous positive airway pressure) mask

Surgical Treatment with multilevel operation

Procedure

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

Other names: Surgical multilevel anti-obstructive operation

Primary outcomes

  1. Neurocognitive function

    Time frame: 4 months

    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.

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

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

Acronym: 203_14_B

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 22, 2015
Registry last updated
Dec 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.