EndoBarrier in Obstructive Sleep Apnoea Study

NACompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

December 31, 2019

Study Completion Date

December 31, 2019

Conditions
Type 2 DiabetesObstructive Sleep ApnoeaObesity
Interventions
DEVICE

EndoBarrier

"During screening visit, a brief history, examination, blood tests and 2 sleep studies within a gap of 1 week will be performed. Then, there will be an assessment by gastroenterologist for EndoBarrier insertion. EndoBarrier will be inserted endoscopically as a day case procedure after the midnight fast, under general anaesthesia. Following the EndoBarrier insertion, there will be 3 monthly trial visits until one year where the following assessments will be performed - brief interview, observations, blood tests, urine test, dietitian review, compliance check with CPAP and quality of life questionnaire.~At the end of one year, EndoBarrier will be removed endoscopically again as a day case procedure under general anaesthesia. Then, there will be follow up trial visits every 3 months up to one year where there will be clinical assessments, sleep studies, blood tests, urine test, dietitian, compliance check and quality of life questionnaires."

Trial Locations (1)

B18 7QH

City Hospital, Birmingham

All Listed Sponsors
collaborator

Association of British Clinical Diabetologists

UNKNOWN

lead

Dr Bob Ryder

OTHER

NCT06376305 - EndoBarrier in Obstructive Sleep Apnoea Study | Biotech Hunter | Biotech Hunter