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

NCT06442163 | Completed

• 1 other identifier: 5000231
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity Hypoventilation Syndrome (OHS)

Keywords

ventilation, Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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 Arms (1)

All Clinically stable OHS patients with a body mass index of 30 kg/m2 and daytime hypercapnia (PaCO2

EXPERIMENTAL

Each participant underwent initial baseline diagnostic polysomnograms (PSG) documenting the presence of OSA based on standard diagnostic criteria. After baseline (PSG) and patient's consent, patients performed full night CPAP titration in the sleep laboratory within 7 days of the baseline PSG, and AVAPS-AE titration.

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.

Interventions

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. DEVICE

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.

All Clinically stable OHS patients with a body mass index of 30 kg/m2 and daytime hypercapnia (PaCO2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit University Hospital

Asyut, Assuit, 711111, Egypt

Location

MeSH Terms

Conditions

Obesity Hypoventilation Syndrome; Respiratory Aspiration; Obesity

Condition Hierarchy (Ancestors)

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Hypoventilation; Respiratory Insufficiency; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Weight; Signs and Symptoms

Study Officials

• Doaa Magdy

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of pulmonary medecine

Study Record Dates

• First Submitted: May 18, 2024
• First Posted: June 4, 2024
• Study Start: May 12, 2020
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)