Who is sponsoring NCT01368614?

NCT01368614 is sponsored by Philips Respironics.

What drugs are being tested in NCT01368614?

Interventions in NCT01368614: AVAPS-AE Mode of Therapy, Respironics OnmiLab BiPAP S mode, Respironics OmniLab Advanced CPAP mode.

What condition does NCT01368614 study?

NCT01368614 studies Obesity Hypoventilation Syndrome.

Is NCT01368614 still recruiting?

NCT01368614 is currently completed. Last updated 26 April 2019.

Are results published for NCT01368614?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-04-26 · How we verify

NCT01368614

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

AVAPS-AE Efficacy Study

Completed NA Results posted Last updated 26 April 2019

What this trial tests

NA trial testing AVAPS-AE Mode of Therapy in Obesity Hypoventilation Syndrome in 90 participants. Completed in 30 May 2013.

Timeline

12 September 2011

Primary endpoint
30 May 2013

30 May 2013

Quick facts

Lead sponsor	Philips Respironics
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	90
Start date	12 September 2011
Primary completion	30 May 2013
Estimated completion	30 May 2013
Sites	2 locations across United States

Drugs / interventions tested

AVAPS-AE Mode of Therapy
Respironics OnmiLab BiPAP S mode
Respironics OmniLab Advanced CPAP mode

Conditions studied

Obesity Hypoventilation Syndrome — all drugs for Obesity Hypoventilation Syndrome →

Sponsor

Philips Respironics

Who can join

Adults 18 to 70, any sex, with Obesity Hypoventilation Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Screening

Group	Value	95% CI
AVAPS-AE	47.1	± 2.5
Respironics OmniLab Advanced BiPAP S Mode	51.8	± 8.0
Respironics OmniLab Advanced CPAP Mode	50.7	± 4.7

Week 6

Group	Value	95% CI
AVAPS-AE	40.7	± 3.7
Respironics OmniLab Advanced BiPAP S Mode	47.4	± 8.9
Respironics OmniLab Advanced CPAP Mode	40.8	± 5.8

Daytime Partial Pressure of Oxygen in Arterial Blood(Pa02) Secondary · 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.

Screening

Group	Value	95% CI
AVAPS-AE	62.8	± 5.8
Respironics OmniLab Advanced BiPAP S Mode	56.9	± 10.7
Respironics OmniLab Advanced CPAP Mode	62.6	± 9.8

Week 6

Group	Value	95% CI
AVAPS-AE	65.0	± 4.5
Respironics OmniLab Advanced BiPAP S Mode	58.7	± 14.7
Respironics OmniLab Advanced CPAP Mode	66.2	± 5.9

Apnea Hypopnea Index (AHI) Secondary · 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.

Screening

Group	Value	95% CI
AVAPS-AE	84.5	± 37.9
Respironics OmniLab Advanced BiPAP S Mode	67.7	± 23.9
Respironics OmniLab Advanced CPAP Mode	85.4	± 33.5

Titration

Group	Value	95% CI
AVAPS-AE	16.1	± 11.6
Respironics OmniLab Advanced BiPAP S Mode	22.4	± 11.1
Respironics OmniLab Advanced CPAP Mode	30.1	± 23.6

Week 6

Group	Value	95% CI
AVAPS-AE	15.5	± 11.8
Respironics OmniLab Advanced BiPAP S Mode	12.4	± 14.8
Respironics OmniLab Advanced CPAP Mode	7.4	± 7.9

Epworth Sleepiness Scale Secondary · 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.

Screening

Group	Value	95% CI
AVAPS-AE	14.9	± 4.8
Respironics OmniLab Advanced BiPAP S Mode	12.0	± 5.2
Respironics OmniLab Advanced CPAP Mode	11.5	± 6.1

Week 6

Group	Value	95% CI
AVAPS-AE	9.8	± 5.8
Respironics OmniLab Advanced BiPAP S Mode	8.1	± 6.1
Respironics OmniLab Advanced CPAP Mode	5.9	± 5.0

Severe Respiratory Insufficiency Questionnaire (SRIQ) Secondary · 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 value

Screening

Group	Value	95% CI
AVAPS-AE	52.0	± 14.5
Respironics OmniLab Advanced BiPAP S Mode	53.4	± 14.5
Respironics OmniLab Advanced CPAP Mode	60.0	± 16.1

Week 6

Group	Value	95% CI
AVAPS-AE	61.0	± 13.5
Respironics OmniLab Advanced BiPAP S Mode	64.8	± 18.4
Respironics OmniLab Advanced CPAP Mode	69.7	± 13.4

Ventilator Adherence - Average Hours Secondary · 6 weeks

The average number of hours ventilator was used per each day used.

Group	Value	95% CI
AVAPS-AE	4.8	± 0.9
Respironics OmniLab Advanced BiPAP S Mode	5.2	± 1.7
Respironics OmniLab Advanced CPAP Mode	6.6	± 0.4

Ventilator Adherence - Days Used Secondary · 6 weeks

Average number of days used per week

Group	Value	95% CI
AVAPS-AE	5.3	± 0.9
Respironics OmniLab Advanced BiPAP S Mode	5.3	± 1.5
Respironics OmniLab Advanced CPAP Mode	6.9	± 0.5

Room Air Sp02 Assessment Via Pulse Oximetry Secondary · Screening & 6 weeks

Oxygen saturation measurements as determined by pulse oximetry

Screening

Group	Value	95% CI
AVAPS-AE	92.5	± 3.4
Respironics OmniLab Advanced BiPAP S Mode	90.6	± 4.1
Respironics OmniLab Advanced CPAP Mode	92.9	± 2.5

Week 6

Group	Value	95% CI
AVAPS-AE	94.6	± 2.0
Respironics OmniLab Advanced BiPAP S Mode	90.1	± 7.2
Respironics OmniLab Advanced CPAP Mode	94.1	± 2.5

Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Duration Secondary · 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.

Total Sleep Time Stage 1- Screening

Group	Value	95% CI
AVAPS-AE	28.4	± 19.5
Respironics OmniLab Advanced BiPAP S Mode	24.6	± 26.6
Respironics OmniLab Advanced CPAP Mode	18.9	± 15.6

Total Sleep Time Stage 1- 6 weeks

Group	Value	95% CI
AVAPS-AE	10.0	± 6.8
Respironics OmniLab Advanced BiPAP S Mode	13.1	± 10.3
Respironics OmniLab Advanced CPAP Mode	10.1	± 7.3

Total Sleep Time Stage 2- Screening

Group	Value	95% CI
AVAPS-AE	50.8	± 15.8
Respironics OmniLab Advanced BiPAP S Mode	59.1	± 22.4
Respironics OmniLab Advanced CPAP Mode	64.8	± 15.8

Total Sleep Time Stage 2-6 weeks

Group	Value	95% CI
AVAPS-AE	59.2	± 15.1
Respironics OmniLab Advanced BiPAP S Mode	52.4	± 14.3
Respironics OmniLab Advanced CPAP Mode	53.2	± 15.4

Total Sleep Time Stage 3/4 - Screening

Group	Value	95% CI
AVAPS-AE	8.5	± 13.7
Respironics OmniLab Advanced BiPAP S Mode	8.1	± 11.7
Respironics OmniLab Advanced CPAP Mode	7.8	± 8.4

Total Sleep Time Stagev3/4-6 weeks

Group	Value	95% CI
AVAPS-AE	12.5	± 13.2
Respironics OmniLab Advanced BiPAP S Mode	14.0	± 10.9
Respironics OmniLab Advanced CPAP Mode	16.6	± 15.8

Total Sleep Time Stage REM- Screening

Group	Value	95% CI
AVAPS-AE	13.5	± 7.4
Respironics OmniLab Advanced BiPAP S Mode	8.2	± 10.1
Respironics OmniLab Advanced CPAP Mode	8.5	± 5.1

Total Sleep Time Stage REM-6 weeks

Group	Value	95% CI
AVAPS-AE	18.3	± 8.9
Respironics OmniLab Advanced BiPAP S Mode	20.4	± 9.1
Respironics OmniLab Advanced CPAP Mode	20.1	± 7.5

Duration and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Sleep Efficiency Secondary · 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.

Sleep Efficiency - Screening

Group	Value	95% CI
AVAPS-AE	74.4	± 14.9
Respironics OmniLab Advanced BiPAP S Mode	64.5	± 14.9
Respironics OmniLab Advanced CPAP Mode	74.6	± 18.9

Sleep Efficiency - 6 weeks

Group	Value	95% CI
AVAPS-AE	86.8	± 8.4
Respironics OmniLab Advanced BiPAP S Mode	71.4	± 17.1
Respironics OmniLab Advanced CPAP Mode	74.4	± 23.8

Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study)- Arousal and Awakening Indices Secondary · Screening & 6 weeks

The arousal index is measured by the average number of arousals or awakenings a participant has over an hour of sleep.

Screening

Group	Value	95% CI
AVAPS-AE	68.2	± 31.2
Respironics OmniLab Advanced BiPAP S Mode	66.0	± 20.9
Respironics OmniLab Advanced CPAP Mode	71.4	± 27.1

6 weeks

Group	Value	95% CI
AVAPS-AE	19.4	± 9.3
Respironics OmniLab Advanced BiPAP S Mode	23.0	± 10.9
Respironics OmniLab Advanced CPAP Mode	21.3	± 10.1

Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study)- Nocturnal O2 Saturation Secondary · Screening & 6 weeks

Measurement of overnight oxygen saturation as measured by percentage of oxygen saturation (SpO2)

Screening

Group	Value	95% CI
AVAPS-AE	84.2	± 6.0
Respironics OmniLab Advanced BiPAP S Mode	81.6	± 7.5
Respironics OmniLab Advanced CPAP Mode	81.1	± 8.5

6 weeks

Group	Value	95% CI
AVAPS-AE	92.7	± 2.5
Respironics OmniLab Advanced BiPAP S Mode	93.3	± 2.9
Respironics OmniLab Advanced CPAP Mode	94.5	± 1.4

Adverse events — posted to ClinicalTrials.gov

Time frame: All Adverse Events experienced over 6 weeks were collected.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

AVAPS-AE

Serious: 0/11 (0%)

Deaths: 0/11

Respironics OmniLab Advanced BiPAP S Mode

Serious: 0/10 (0%)

Deaths: 0/10

Respironics OmniLab Advanced CPAP Mode

Serious: 2/11 (18%)

Deaths: 0/11

Serious adverse events (2 terms)

Reaction	System	AVAPS-AE	Respironics OmniLab Advanc…	Respironics OmniLab Advanc…
Chest Pain	Cardiac disorders	—	—	—
Fournier's Gangrene	Renal and urinary disorders	—	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	AVAPS-AE	Respironics OmniLab Advanc…	Respironics OmniLab Advanc…
Chest Pain	Cardiac disorders	—	—	—

Most-reported serious reactions: Chest Pain, Fournier's Gangrene.

Data from ClinicalTrials.gov NCT01368614 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Exosomal Cargo Properties, Endothelial Function and Treatment of Obesity Hypoventilation Syndrome: A Proof of Concept Study.
Bhattacharjee R, Khalyfa A, Khalyfa AA, Mokhlesi B, et al · · 2018 · cited 31× · PMID 29734990 · DOI 10.5664/jcsm.7110
Positive airway pressure improves nocturnal beat-to-beat blood pressure surges in obesity hypoventilation syndrome with obstructive sleep apnea.
Carter JR, Fonkoue IT, Grimaldi D, Emami L, et al · · 2016 · cited 12× · PMID 26818059 · DOI 10.1152/ajpregu.00516.2015
CPAP titration failure is not equivalent to long-term CPAP treatment failure in patients with obesity hypoventilation syndrome: a case series.
Lastra AC, Masa JF, Mokhlesi B. · · 2020 · cited 3× · PMID 32713421 · DOI 10.5664/jcsm.8712
Deep learning applied to polysomnography to predict blood pressure in obstructive sleep apnea and obesity hypoventilation: a proof-of-concept study.
Prasad B, Agarwal C, Schonfeld E, Schonfeld D, et al · · 2020 · cited 2× · PMID 32484157 · DOI 10.5664/jcsm.8608

Verify or expand the search:

Other Philips Respironics trials

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01368614 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Philips Respironics
Last refreshed: 26 April 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01368614.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01368614

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (2 terms)

Sponsor's own description

Publications & conference data

Related trials

Other Philips Respironics trials

Verify against primary sources