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Clinical Trials/ACTRN12615000122550
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.

Registry
who.int
Start Date
February 11, 2015
End Date
TBD
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sheila Sivam

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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