EndoBarrier in Obstructive Sleep Apnoea Study

Obesity Clinical Trial

— End-OSA  

Official title:

EndoBarrier Obstructive Sleep Apnoea Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06376305
• Other study ID #: 176786
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: December 2019

Study information

• Verified date: April 2024
• Source: Sandwell & West Birmingham Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Obstructive sleep apnoea (OSA) is a common condition in which the upper airways (windpipe) collapse repeatedly during sleep, blocking the flow of air into the lungs. It is characterized by repetitive pauses in breathing during sleep, despite the effort to breathe, and is associated with a reduction in the amount of oxygen in the blood (oxygen saturation). People with OSA are at risk of heart disease, high blood pressure, stroke, depression, and premature death. OSA is usually treated using a continuous positive airway pressure (CPAP) machine. This involves the patient wearing a face mask during sleep which is connected to the machine which supplies a constant steam of air to help keep the airways open. This improves the symptoms and hopefully the long-term outlook, but it is an uncomfortable solution. OSA is associated with obesity and weight loss can improve or even cure it. Treatment with EndoBarrier (placement of a thin flexible tube that is placed inside your intestine creating a physical barrier between the intestinal wall and the food so less can be absorbed) can be associated with significant weight loss and can improve blood sugar control in patients with type 2 diabetes related to their weight (diabesity). This study aims to find out if EndoBarrier treatment can improve OSA in patients with diabesity to the extent that some patients no longer require their CPAP machine treatment.

Description:

Once the participant has decided to take part in the study, they will be invited for signing a consent form and screening checks which will include medical history, examination, blood tests (approximately 10 ml) and sleep studies (at home without CPAP) on two occasions within one week to determine whether they are eligible for the study. If they fulfil all the criteria and once recruited into the study, they will be assessed for placement of EndoBarrier by gastroenterologists (tummy doctors) followed by its insertion in City Hospital as a day case procedure. There may be individual or group information sessions including the use of models and videos to describe insertion and removal of EndoBarrier devices. Potential participants will be offered the opportunity to ask questions. There will be trial assessment visits for every 3 months until one year after the insertion of EndoBarrier and then for every 3 months up to one year following its removal. During these visits, participants are assessed clinically and have blood tests (approximately 10 ml taken in a fasted state), sleep studies and quality of life questionnaires. EndoBarrier will be removed after 1 year, again, as a day case procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Moderate OSA on CPAP fulfilling NICE criteria for CPAP(AHI between 15 and 29 with symptoms)
• Prediabetes(HbA1c between 42 & 48 mmol/mol) or confirmed type 2 diabetes (HbA1C=48mmol/mol)
• Obesity BMI =30 and =45 Kg/m2
• Age = 18 years
• Capable of giving informed consent

Exclusion Criteria:

• Abnormal intestinal anatomy
• Contraindication to oesophagogastroduoenoscopy
• Previous bariatric surgery or bowel surgery
• Active infection
• Anticoagulation therapy
• Coagulopathy INR >1.3
• Estimated Glomerular Filtration Rate (eGFR)<30
• Known portal hypertension
• Uncontrolled cardiovascular disease
• Lactating or pregnant females
• Excess anaesthetic risk
• Patients taking non-steroidal anti-inflammatory agents will need to discontinue these for the duration of Endobarrier implantation
• Patients taking aspirin/clopidogrel with active ischaemic heart disease or cerebrovascular disease(secondary prevention)

Related Conditions & MeSH terms

• Apnea
• Obesity
• Obstructive Sleep Apnoea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	City Hospital	Birmingham

Sponsors (2)

Lead Sponsor	Collaborator
Dr Bob Ryder	Association of British Clinical Diabetologists

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

de Jonge C, Rensen SS, Verdam FJ, Vincent RP, Bloom SR, Buurman WA, le Roux CW, Schaper NC, Bouvy ND, Greve JW. Endoscopic duodenal-jejunal bypass liner rapidly improves type 2 diabetes. Obes Surg. 2013 Sep;23(9):1354-60. doi: 10.1007/s11695-013-0921-3. — View Citation

Schouten R, Rijs CS, Bouvy ND, Hameeteman W, Koek GH, Janssen IM, Greve JW. A multicenter, randomized efficacy study of the EndoBarrier Gastrointestinal Liner for presurgical weight loss prior to bariatric surgery. Ann Surg. 2010 Feb;251(2):236-43. doi: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Requirement for continuous positive airway pressure (CPAP) treatment will be assessed by sleep studies at screening and then every 3 months, up to 24 months	Requirement for continuous positive airway pressure	Every 3 months, up to 24 months
Secondary	Apnea-hypopnea index (AHI) is measured by sleep studies at screening and then every 3 months, up to 24 months	Apnea-hypopnea index (AHI)	Every 3 months, up to 24 months
Secondary	Obstructive sleep apnoea (OSA) symptoms are measured by sleep studies at screening, and then every 3 months, up to 24 months	Obstructive sleep apnoea (OSA) symptoms	Every 3 months, up to 24 months
Secondary	Continuous positive airway pressure (CPAP) pressures are measured by sleep studies at screening, and then every 3 months, up to 24 months	Continuous positive airway pressure (CPAP) pressures	Every 3 months, up to 24 months
Secondary	Glycated haemoglobin measured by blood test (HbA1c) at screening, baseline, and then every 3 months, up to 24 months	Glycated haemoglobin	Every 3 months, up to 24 months
Secondary	Fasting plasma glucose is measured by blood test(fasting plasma glucose) at baseline, and then at 12 and 24 months	Fasting plasma glucose	At baseline, and then at 12 and 24 months
Secondary	Weight and Body mass index (BMI) is measured by checking weight in kilograms as well as height (in metres) ( weight and height will be combined to report BMI in kg/m^2) at screening, baseline, and then every 3 months, up to 24 months	Weight and Body mass index (BMI)	Every 3 months, up to 24 months
Secondary	Composite scores of NAFLD severity derived from the blood measurements of Alanine Aminotransferase in U/L, Aspartate Aminotransferase in U/L, platelets in x10^9/L and serum albumin in g/L as well as age in years and BMI	Composite scores of NAFLD severity	At screening, baseline, and then every 3 months, up to 24 months
Secondary	Circulating free testosterone, fasting insulin and C-Peptide are measured by blood tests at baseline, and then at 3, 12 and 24 months	Circulating free testosterone, fasting insulin and C-Peptide	At baseline, and then at 3, 12 and 24 months
Secondary	Blood pressure is measured by checking blood pressure at sitting at screening, baseline, and then every 3 months, up to 24 months	Blood pressure	Every 3 months, up to 24 months
Secondary	Diabetes treatment including need for insulin is measured at baseline, and then every 3 months, up to 24 months21 and 24 months	Diabetes treatment	Every 3 months, up to 24 months
Secondary	Quality of life scores is measured by EQ-5D questionnaire at baseline and then at 6, 12 and 24 months	Quality of life score	At baseline and then at 6, 12 and 24 months