Average Volume-assured Pressure Support as Rescue Therapy in Obesity Hypoventilation Syndrome

Obesity Hypoventilation Syndrome (OHS) Clinical Trial

— AVAPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06442163
• Other study ID #: 5000231
• Status: Completed
• Phase: N/A
• Start date: May 12, 2020
• Est. completion date: April 30, 2024

Study information

• Verified date: June 2024
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoventilation
• Obesity
• Obesity Hypoventilation Syndrome
• Obesity Hypoventilation Syndrome (OHS)
• Syndrome

Intervention

Device:
• AVAPS study was performed within 1 week of the CPAP titration attempt failure, using the auto-titrating EPAP (AE), the OmniLab Advanced +, System One device (Philips Respironics, Murrysville, PA, U.S.
After attending an educational session (in the presence of a family member) with hands-on training, the AVAP -AE devices were provided to the patients. During the study, one month after AVAPS -AE initiation, patients had direct immediate access to medical and technical support through phone contact during daytime working hours.

Locations

Country	Name	City	State
Egypt	Assuit University Hospital	Assiut	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the initial diagnostic, and therapeutic sleep study parameters using either CPAP and (AVAPS-AE) titration study in patients with OHS.	polysomnographic parameter (apnea hypopnea index (events/hours)	1 week
Secondary	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.	Patients had follow-up appointments at two distinct time points, after 3 month and final visit after 6 month of home AVAPS- AE therapy, to address sleep quality using: Self-assessed sleep quality (0: very poor/10: very good). Objective assessment of adherence to AVAPS- AE therapy was recorded. The ATS criteria defined "good adherence" to PAP as "using PAP therapy regularly for > 4 h/night for >70% of the recorded time"	at 1 ,3,6 months