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Completed

NCT Number: NCT06442163

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assuit University Hospital

Asyut, Assuit, 711111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

    Time frame: 1 week

    polysomnographic parameter (apnea hypopnea index (events/hours)

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.

    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"

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study 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

Acronym: AVAPS

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 4, 2024
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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