Average Volume-assured Pressure Support as Rescue Therapy in Obesity Hypoventilation Syndrome (AVAPS)
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
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Assuit
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Assiut, Assuit, Egypt, 711111
- Assuit University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: All Clinically stable OHS patients with a body mass index of 30 kg/m2 and daytime hypercapnia (PaCO2
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
Time Frame: at 1 ,3,6 months
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Doaa Magdy, Assiut University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Respiratory Tract Diseases
- Apnea
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Disease
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Signs and Symptoms, Respiratory
- Sleep Apnea Syndromes
- Respiratory Insufficiency
- Sleep Apnea, Obstructive
- Syndrome
- Obesity
- Hypoventilation
- Obesity Hypoventilation Syndrome
Other Study ID Numbers
- 5000231
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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