Pathophysiology of Hypoventilation in Obesity and Effects of Bariatric Intervention (PHOEBI)

Guy's and St Thomas' NHS Foundation Trust

Status: Enrolling

Conditions: Obesity Hypoventilation Syndrome (OHS)

Treatments: Procedure: Bariatric Surgery

Study type: Observational

Funder types: Other

Identifiers

NCT04025528

258045

Details and patient eligibility

About

Breathing is impacted by obesity. Early changes are characterised by significant breathing abnormalities during sleep (a condition called sleep disordered breathing, the most common of which is obstructive sleep apnoea). As the breathing changes worsen in severity, it may result in a rise in carbon dioxide levels during daytime causing a condition called obesity hypoventilation syndrome (OHS). The current treatment for obesity related breathing changes include supportive breathing therapy at night, optimisation of associated medical conditions and weight loss.

Weight management is an important part of obesity treatment. Weight loss strategies such as life-style modification do not always work. Weight loss surgery (bariatric surgery) has been shown to be an effective weight management intervention with long-term results. This study aims to understand breathing changes that occurs due to obesity and their resolution after weight loss surgery. The investigators are aiming to recruit participants with sleep disordered breathing who are currently awaiting bariatric surgery. In particular, the investigators are interested in comparing breathing changes in participants with OHS, who have abnormal regulation of their carbon dioxide levels, and participants with sleep disordered breathing with normal CO2 regulation.

Participants will be recruited through outpatient clinics for sleep disordered breathing. The participants will undergo comprehensive breathing assessments on enrolment including an overnight sleep study. Participants will undergo further daytime breathing assessments before and after their bariatric surgery. End of study will be 6 months after surgery - participants will have a final comprehensive breathing assessment including an overnight sleep study to review resolution of their breathing changes. Depending on the wait list time for the bariatric surgery, it is anticipated that participants will be enrolled in the study for 2 years.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients 18 years or older
2. BMI > 40
3. Patients with significant sleep disordered breathing requiring treatment
4. Patient is being assessed for bariatric surgery for either gastric sleeve or gastric bypass surgery

Exclusion criteria

1. Patients with decompensated hypercapnic respiratory failure (pH< 7.3)
2. Chronic hypercapnic respiratory failure due to a cause other than obesity such as neuromuscular, chest wall or airway disease
3. Unstable cardiac disease including coronary artery disease and heart failure
4. Significant co-morbid psychiatric disease requiring anti-psychotic medications
5. Chronic pain syndrome on high dose opioid medications
6. Treatment for drug or alcohol addiction
7. Cognitive impairment that would prevent informed consent
8. Pregnancy
9. Need for long-term renal replacement therapy
10. Patients who undergo bariatric intervention with gastric balloon or gastric band.

Trial design

30 participants in 2 patient groups

Hypercapnic

Description:

Obese patients with daytime hypercapnia

Treatment:

Procedure: Bariatric Surgery

Eucapnic

Description:

Obese patients with normal daytime carbon dioxide levels

Treatment:

Procedure: Bariatric Surgery