Obesity Hypoventilation Syndrome (OHS)AVAPSNCT06442163
Average Volume-assured Pressure Support as Rescue Therapy in Obesity Hypoventilation Syndrome
A study testing 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. in people with Obesity Hypoventilation Syndrome (OHS), run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity Hypoventilation Syndrome (OHS)
- What is being tested?
- 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.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 12 May 2020to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Obesity Hypoventilation Syndrome (OHS)
- Being tested
- 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.
- Keywords
- ventilation, Obesity
- Medical subject headings
- Obesity Hypoventilation Syndrome, Respiratory Aspiration, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
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"
Measured: at 1 ,3,6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start12 May 2020
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity Hypoventilation Syndrome (OHS)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Magdy Eid, Assiut University
- Investigators
- Doaa Magdy, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442163
- Sponsor's protocol ID
- 5000231
- Acronym
- AVAPS
- Status last verified
- Jun 2024
- First submitted
- 18 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: after being published
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06442163
- Acronym / sponsor ID
- AVAPS / 5000231
- Conditions
- Obesity Hypoventilation Syndrome (OHS)
- Keywords
- ventilation, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 12 May 2020 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Clinically stable OHS patients with a body mass index of 30 kg/m2 and daytime hypercapnia (PaCO2 | Experimental | 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.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All Clinically stable OHS patients with
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | All Clinically stable OHS patients with a body mass index of 30 kg/m2 and daytime hypercapnia (PaCO2 |
Primary outcome
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 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: No. after being published
Related trials for Obesity Hypoventilation Syndrome (OHS)
Not yet recruiting
Hypercapnic Burden in Adults With Obesity Undergoing Diagnostic Polysomnography for Suspected Obstructive Sleep Apnea
Obstructive Sleep Apnea, Obesity (BMI>30)
RecruitingObservational study
The Use of Entropy to Assess Sleep Disordered Breathing in Chronic Respiratory Disease
Bronchial Asthma, Bronchiectasis
Not yet recruiting
The Effect of Mask Design on Ventilation Parameters in COPD and OHS Patients on Long-term Home Non-invasive Ventilation. An Experimental Study.
COPD (Chronic Obstructive Pulmonary Disease), Obesity Hypoventilation Syndrome (OHS)
Recruiting
Assessment of Breathing Pattern During NIV
COPD (Chronic Obstructive Pulmonary Disease), Obesity Hypoventilation Syndrome (OHS)
Not yet recruitingObservational study
Evaluation of Upper Extremity Functions in Obesity Hypoventilation Syndrome Patients
Obesity Hypoventilation Syndrome (OHS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doaa Magdy principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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. in people with Obesity Hypoventilation Syndrome (OHS), run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.