Status:

UNKNOWN

Pathophysiology of Hypoventilation in Obesity and Effects of Bariatric Intervention

Lead Sponsor:

Guy's and St Thomas' NHS Foundation Trust

Conditions:

Obesity Hypoventilation Syndrome (OHS)

Eligibility:

All Genders

18-80 years

Brief Summary

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 obstru...

Eligibility Criteria

Inclusion

  • Patients 18 years or older
  • BMI \> 40
  • Patients with significant sleep disordered breathing requiring treatment
  • Patient is being assessed for bariatric surgery for either gastric sleeve or gastric bypass surgery

Exclusion

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

Key Trial Info

Start Date :

June 20 2019

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

July 1 2024

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT04025528

Start Date

June 20 2019

End Date

July 1 2024

Last Update

March 23 2023

Active Locations (1)

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1

Guy's and St Thomas' NHS Trust

London, United Kingdom, SE17EH