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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01483716
Other study ID # 11/LO/1481
Secondary ID
Status Completed
Phase N/A
First received November 30, 2011
Last updated August 16, 2015
Start date November 2011
Est. completion date August 2015

Study information

Verified date August 2015
Source Guy's and St Thomas' NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Interventional

Clinical Trial 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 breathlessness, reduction in exercise capacity, fatigue and headaches. Previous research has shown that patients with this condition tend to use healthcare services more frequently and are often at risk of other diseases such as diabetes mellitus and high blood pressure. Currently, the mainstay of treatment is noninvasive ventilation (NIV), this is a mask ventilator that patients use overnight to improve oxygen levels and remove carbon dioxide (the waste gas of breathing), however this does not fully treat the underlying problem. The research group has shown that NIV helps improve activity and contributes to weight loss in this group of patients. The aim of this research will be to investigate the effect of an exercise and nutrition programme in addition to NIV on weight loss and activity levels compared to NIV alone.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date August 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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 Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Rehabilitation


Locations

Country Name City State
United Kingdom Guy's and St Thomas' NHS Trust London

Sponsors (1)

Lead Sponsor Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary % Weight loss 12 months No
Secondary 6 minute walk test 12 months No
See also
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Completed NCT02342899 - Cost Effectiveness of Outpatient Set-up of Automated NIV in Obese Patients With Chronic Respiratory Failure Phase 3
Completed NCT01757444 - Non Invasive Ventilation : Efficacy of a New Ventilatory Mode in Patients With OHS N/A