Predicting the successful resolution of Obstructive Sleep Apnoea following weight-loss surgery

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12619001505190

Acronym

BAROSA

Enrollment

Registered

2019-10-31

Start date

2019-08-20

Completion date

2022-04-22

Last updated

2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Obstructive sleep apnoea (OSA) is a common disorder and is an independent risk factor for cardiovascular morbidity and mortality, making OSA a major health concern. Importantly obesity, which is the strongest risk factor for OSA, is a growing epidemic and is one the western world’s leading health care concerns. However, the exact mechanisms by which obesity increases the risk of OSA are poorly understood. Therefore, this study aims to examine the effect that obesity has on the underlying physiology known to cause OSA. Using well-established physiological and imaging techniques, we will measure the physiology both before and after weight loss surgery in a group of obese OSA patients. Additionally, using all the variables measured in this study, we aim to be able to predict the important factors involved in the successful resolution of OSA following weight loss. Understanding the important factor(s) involved linking obesity with OSA is crucial for developing more effective interventions and treatment strategies.

Interventions

Longitudinal study of Obstructive Sleep Apnoea (OSA) patients scheduled to undergo weight-loss surgery with a Sleeve Gastrectomy. Patient's sleep (i.e. OSA severity) and physiological traits will be assessed via two overnight sleep studies before surgery and at least 6-months post-surgery in order to assess how the trajectory of weight-loss over time relates to the improvement in OSA and its underlying physiology.

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

• Ability to consent • Moderate/severe OSA (Apnoea Hypopnea Index [AHI] > 15) • Body Mass Index (BMI) of 35-55 • Scheduled to undergo a sleeve gastrectomy surgery for weight-loss • Patients will be otherwise healthy (except for treated hypertension and diabetes)

Exclusion criteria

• Untreated medical problems other than OSA • Patients with safety concerns (drowsy driving within the past 1 year) • Receiving medication that could affect ventilation (i.e. morphine derivatives, benzodiazepines, theophylline) or muscle control. • Allergy to lidocaine or oxymetazoline • Previous surgical treatment for OSA and/or obesity • Women who are pregnant or breastfeeding

Outcome results