AVAPS-AE Efficacy Study

Randomized Controlled Trial Evaluating the Feasibility of AVAPS-AE vs. CPAP vs.Bilevel Pressure Support Ventilation in Obesity Hypoventilation Syndrome

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01368614

Enrollment

Registered

2011-06-08

Start date

2011-09-12

Completion date

2013-05-30

Last updated

2019-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity Hypoventilation Syndrome

Keywords

OHS

Brief summary

The purpose of this study is to evaluate the feasibility of using of the Average Volume Assured Pressure Support (AVAPS-AE) mode versus Continuous Positive Airway Pressure (CPAP) and bilevel pressure support ventilation (PSV) modes of ventilation in patients diagnosed with Obesity Hypoventilation syndrome (OHS). The investigators believe the use of the AVAPS-AE mode of ventilation after 6 weeks will yield daytime gas exchange values which are equivalent or no worse when compared to using CPAP and bilevel PSV modes of ventilation in the OHS population.

Interventions

DEVICEAVAPS-AE Mode of Therapy

AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.

DEVICERespironics OnmiLab BiPAP S mode

Currently cleared Non-Invasive Ventilation (NIV) therapy modality

DEVICERespironics OmniLab Advanced CPAP mode

Currently cleared NIV therapy modality

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Age greater than or equal to 18 years of age; less than or equal to 70 years of age * Diagnosis of Obesity Hypoventilation Syndrome via a diagnostic sleep study in the past 3 months but have not initiated therapy * BMI greater than or equal to 30 kg/m2 * Daytime PaCO2 greater than or equal to 45 mmHg * Apnea Hypopnea index (AHI) \> 5 * Daytime pH \> 7.35 * Forced Expiratory Volume at 1 second / forced vital capacity (FEV1/FVC) \> 70%

Exclusion criteria

* Acutely ill, medically complicated or who are medically stable, or as otherwise determined by the investigator * Respiratory alkalosis (pH \> 7.45), per investigator discretion * Emergency admissions on chronic respiratory failure * Hospitalization for respiratory exacerbation \< 6 weeks prior to screening visit * Participants in whom PAP therapy is otherwise medically contraindicated * Impaired upper airway function. For example, obstruction due to infections(laryngitis, epiglottis), craniofacial malformations, tumors, uvulopalatopharyngoplasty, presence of tracheostomy, or bilateral vocal cord palsy that does not allow tolerance of Non-invasive positive pressure ventilation (NPPV) * Facial trauma, burns, surgery or anatomical abnormalities interfering with mask fit.

Design outcomes

Primary

Measure	Time frame	Description
Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2)	Screening & 6 weeks	Daytime PaCO2 measurements will be assessed for all randomized patients to each mode of ventilation therapy (AVAPS-AE, bilevel PSV, CPAP) after 6 weeks.

Secondary

Measure	Time frame	Description
Apnea Hypopnea Index (AHI)	Screening & 6 weeks	The AHI is the number of apneas and hypopneas per hour of sleep. It will be evaluated during the screening sleep study and the 6 week follow up sleep study. AHI less than 5 is considered normal. For an Apnea-Hypopnea Index (or AHI) from 5 to 15 denotes mild sleep apnea. Fifteen to 30 is moderate, while a greater than 30 AHI is considered severe.
Epworth Sleepiness Scale	Screening & 6 weeks	Epworth Sleepiness scale is a measure of daytime sleepiness. It is a series of 8 questions answered on a scale of 0 to 3, 0 being no chance of dozing and 3 being a high chance of dozing. The range of the scale is 0 to 24. The higher the total score, the higher the chance of falling asleep.
Severe Respiratory Insufficiency Questionnaire (SRIQ)	Screening & 6 weeks	The SRIQ is a 49 question survey. This survey asks questions about the past week. It is answered on a scale of -2 to 2 and converted to 1 to 5, 1 is completely untrue and 5 is always true. The questionnaire is broken down into 7 sections when scoring: respiratory complaints, physical functioning, attendant systems and sleep, social relationships, anxiety, psychological well-being and social functioning. Once each scale score is calculated. The average score can be calculated by taking the mean of the subscales. This process of transformation produces a score between 0 and 100 with higher values indicating a better health-related quality of life according to content of the scale.
Ventilator Adherence - Average Hours	6 weeks	The average number of hours ventilator was used per each day used.
Ventilator Adherence - Days Used	6 weeks	Average number of days used per week
Actigraphy	Screening & 6 weeks	Actigraphy is a method of measuring activity and sleep which is achieved by wearing a small watch-like device for an extended period of time. The data is intended to provide an objective measure of physical activity and sleep / week patterns during pre / post sleep studies and throughout the 6 weeks of home use.
Room Air Sp02 Assessment Via Pulse Oximetry	Screening & 6 weeks	Oxygen saturation measurements as determined by pulse oximetry
Daytime Partial Pressure of Oxygen in Arterial Blood(Pa02)	Screening & 6 weeks	Daytime Pa02 measurements will be assessed for all randomized patients to each mode of ventilation therapy (AVAPS-AE, bilevel PSV, CPAP) after 6 weeks.
Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Duration	Screening & 6 weeks	Duration, efficiency and quality of sleepiness are measured by a number of different parameters. Total sleep time in each stage provides the average amount of time a participant was in that stage of sleep. This includes Stage 1, Stage 2, Stage 3/4, and Rapid Eye Movement (REM) sleep.
Duration and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Sleep Efficiency	Screening & 6 weeks	Duration, efficiency and quality of sleepiness are measured by a number of different parameters. Sleep efficiency is measured by the total time a participant is spent asleep.
Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study)- Arousal and Awakening Indices	Screening & 6 weeks	The arousal index is measured by the average number of arousals or awakenings a participant has over an hour of sleep.
Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study)- Nocturnal O2 Saturation	Screening & 6 weeks	Measurement of overnight oxygen saturation as measured by percentage of oxygen saturation (SpO2)
Reaction Time (Psychomotor Vigilance Test-PVT)	Screening & 6 weeks	To measure trends of vigilance between the baseline screening assessment and the 6 week follow up visit comparing the three Arms/Groups. This measured how quickly participants reacted to visual stimulus. Reaction time is the latency at which the participant reacts to a visual stimulus \> 100 ms.
Number of Participants With Need for Continued Oxygen Supplementation	Screening & 6 weeks	Some users enrolled into the study required supplemental oxygen at different times during the day: at rest, during exertion and at night. The need for supplemental oxygen was compared at baseline and at 6 weeks.
Nocturnal Transcutaneous Capnography (TcC02)	Screening & 6 weeks	Nocturnal Transcutaneous Capnography is a non-invasive monitoring tool to measure ventilation over the night. .

Countries

United States

Participant flow

Participants by arm

Arm	Count
All Study Participants All study participants that signed the consent are included in the baseline characteristics to due the high screen failure rate and large number of participants that discontinued the study.	90
Total	90

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Screening Period	Screen Failure	58	0	0	0
Study Period	Lost to Follow-up	0	0	1	0
Study Period	Withdrawal by Subject	0	1	1	3

Baseline characteristics

Characteristic	All Study Participants
Age, Continuous	50.0 years STANDARD_DEVIATION 12.4
Body Mass Index (BMI)	49.3 kg/m^2 STANDARD_DEVIATION 10.2
Race (NIH/OMB) American Indian or Alaska Native	1 Participants
Race (NIH/OMB) Asian	1 Participants
Race (NIH/OMB) Black or African American	41 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	14 Participants
Race (NIH/OMB) White	33 Participants
Region of Enrollment United States	90 participants
Sex: Female, Male Female	30 Participants
Sex: Female, Male Male	60 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 11	0 / 10	0 / 11
other Total, other adverse events	1 / 11	0 / 10	1 / 11
serious Total, serious adverse events	0 / 11	0 / 10	2 / 11

Outcome results

Primary

Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2)

Daytime PaCO2 measurements will be assessed for all randomized patients to each mode of ventilation therapy (AVAPS-AE, bilevel PSV, CPAP) after 6 weeks.