EndoBarrier in Obstructive Sleep Apnoea Study

NCT06376305 | Completed

• 1 other identifier: 176786
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes; Obstructive Sleep Apnoea; Obesity

Keywords

EndoBarrier

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Apnea-hypopnea index (AHI) is measured by sleep studies at screening and then every 3 months, up to 24 months

  Every 3 months, up to 24 months

• Obstructive sleep apnoea (OSA) symptoms are measured by sleep studies at screening, and then every 3 months, up to 24 months

  Every 3 months, up to 24 months

• Continuous positive airway pressure (CPAP) pressures are measured by sleep studies at screening, and then every 3 months, up to 24 months

  Every 3 months, up to 24 months

• Glycated haemoglobin measured by blood test (HbA1c) at screening, baseline, and then every 3 months, up to 24 months

  Every 3 months, up to 24 months

• Fasting plasma glucose is measured by blood test(fasting plasma glucose) at baseline, and then at 12 and 24 months

  At baseline, and then at 12 and 24 months

Study Arms (1)

EndoBarrier in diabetes with obstructive sleep apnoea

OTHER

The arm will consist of patients diabetes or prediabetes who also have moderate obstructive sleep apnoea requiring continuous positive pressure ventilation

Device: EndoBarrier

Interventions

EndoBarrier DEVICE

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.

EndoBarrier in diabetes with obstructive sleep apnoea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dr Bob Ryder: lead
• Association of British Clinical Diabetologists: collaborator

Study Sites (1)

City Hospital

Birmingham, B18 7QH, United Kingdom

Location

Related 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.

  PMID: 23526068 RESULT

• 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: 10.1097/SLA.0b013e3181bdfbff.

  PMID: 19858703 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Sleep Apnea, Obstructive; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 19, 2024
• Study Start: March 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

GB (1)