ACTRN12615000122550
Completed
N/A
An observational study comparing neurocognitive function of obese patients with sleep disordered breathing with and without chronically elevated arterial carbon dioxide levels before and after 3 months of positive pressure mask therapy.
Sheila Sivam0 sites60 target enrollmentFebruary 11, 2015
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Obesity Hypoventilation Syndrome
- Sponsor
- Sheila Sivam
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Age 18 – 75 years old
- •2\.Written informed consent
- •3\.Daytime CO2 \> 45 (OHS) or \< 45 (Control)
- •4\.Evidence of definite OSA on polysomnography, with an AHI \>20 /hr OR evidence of sleep hypoventilation if AHI \<20/hr
- •\*Increase in TcCO2 to a value \> 55mmHg for \>10 mins or
- •\*Increase in TcCO2 \> 10 mmHg (compared with awake PaCO2\) to a value \> 50 mmHg for \> 10 mins)
- •5\.BMI\>40kg/m2
- •6\.pH is in the normal range for chronic hypercapnia
- •7\.FEV1/FVC ratio \> 0\.7
Exclusion Criteria
- •1\.Major psychiatric, neurological disorder or head injury
- •2\.Neuromuscular disease or lung disease
- •3\.FEV1/FVC ratio \<0\.7
- •4\.Uncontrolled medical conditions including cardiac failure
- •5\.Alcohol consumption \>30 g/day or on medications potentially affecting cognitive testing or EEG recordings such as opiates, benzodiazepines, anti\-depressants and anticonvulsants (unless on stable low dose).
- •6\.Not proficient in English
Outcomes
Primary Outcomes
Not specified
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