Status:
COMPLETED
A Trial of Rehabilitation in Obesity Hypoventilation Syndrome (OHS)
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Conditions:
Obesity Hypoventilation Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Obesity is an escalating problem in the UK and a proportion of these patients have a condition known as Obesity Hypoventilation Syndrome (OHS). This syndrome is associated with symptoms of breathlessn...
Eligibility Criteria
Inclusion
- Diagnosis of OHS
- Age \>18
- BMI \> 30 kg/m2
- Chronic hypercapnia , daytime PaCO2 \>6kPa
- FEV1/FVC ≥70%
- Evidence of sleep disordered breathing on overnight studies
- Tolerated NIV \> 4hrs on 1st night during initiation of NIV
Exclusion
- Hypercapnic respiratory failure secondary to an identifiable cause other than OHS.
- Age \<18
- Respiratory acidosis (pH \<7.35)
- Wheelchair/bedbound patients
- Cognitive impairment which would prevent the subject from complying with trial protocol
- Unstable coronary artery syndrome
- Patients postintubation or decannulation following treatment requiring acute hypercapnic respiratory failure
- Patients undergoing renal replacement therapy
- Critical peripheral vascular disease
- Disabling locomotor disability preventing participation in exercises involved in the rehabilitation programme
- Pregnancy
- Bariatric surgery planned within 3 months
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01483716
Start Date
November 1 2011
End Date
August 1 2015
Last Update
August 18 2015
Active Locations (1)
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1
Guy's and St Thomas' NHS Trust
London, United Kingdom, SE1 7EH