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Clinical Trials/NCT06442163
NCT06442163
Completed
Not Applicable

Outcome Measures of Auto-titrating Average Volume-assured Pressure Support (AVAPS) as Rescue Therapy After CPAP Titration Failure in Patients With Obesity Hypoventilation Syndrome: Adherence and Sleep Quality

Assiut University1 site in 1 country20 target enrollmentMay 12, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity Hypoventilation Syndrome (OHS)
Sponsor
Assiut University
Enrollment
20
Locations
1
Primary Endpoint
To compare the initial diagnostic, and therapeutic sleep study parameters using either CPAP and (AVAPS-AE) titration study in patients with OHS.
Status
Completed
Last Updated
last year

Overview

Brief Summary

It remains unclear whether CPAP therapy should be prescribed if significant hypoxemia persists during CPAP titration, despite optimization of upper airway obstructive events, if maximum CPAP pressure is reached.

The goal was to examine the effects of 6 months of home AVAPS therapy in patients with obesity hypoventilation syndrome as a potential option for patients who failed CPAP titration due to persistent hypoxemia.

Detailed Description

Obesity hypoventilation syndrome (OHS) is one of the leading indications of home non-invasive ventilation (NIV) initiation. In patients with OHS, NIV improves daytime vigilance, decreases PaCO2, improves sleep quality, and improves physical activity. Thus, the primary aim of this study was to evaluate the effects of 6-month noninvasive ventilation with average volume-assured pressure support (AVAPS-AE) ventilation on objective sleep quality and adherence to therapy in stable patients with OHS who failed CPAP titration.

Registry
clinicaltrials.gov
Start Date
May 12, 2020
End Date
April 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Doaa Magdy Eid

professor of pulmonary medecine

Assiut University

Eligibility Criteria

Inclusion Criteria

  • All Clinically stable OHS patients with
  • Body mass index of 30 kg/m2 ,
  • Daytime hypercapnia (PaCO2 \>45 mm Hg) who had failed to respond to CPAP therapy
  • had no other cause for their chronic respiratory failure and were naive to any PAP therapy.

Exclusion Criteria

  • Patients with evidence of acute respiratory failure (patients with worsening symptoms during the last 2 weeks before the screening visit, a breathing frequency of 30 breaths/ minute, or signs of respiratory infections)
  • Patients who had been intubated during the last 3 months
  • Patients who had received any other form of ventilatory support before hospital admission were also excluded from the study

Outcomes

Primary Outcomes

To compare the initial diagnostic, and therapeutic sleep study parameters using either CPAP and (AVAPS-AE) titration study in patients with OHS.

Time Frame: 1 week

polysomnographic parameter (apnea hypopnea index (events/hours)

Secondary Outcomes

  • The effects of 6 month of home AVAPS- AE therapy on patient adherence and sleep quality in OHS patients who failed CPAP titration due to persistent hypoxemia.(at 1 ,3,6 months)

Study Sites (1)

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