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OpenTrials
Completed

NCT Number: NCT00772044

Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea

Primary Endpoints:

•Comparison of difference in AHI at one-week in-lab polysomnography between "device on" and "device off" nights, controlling for sleep position (supine vs. non-supine)

Secondary Endpoints: By polysomnography, reduction in:

* AHI with device on vs. off at 3 months, controlling for sleep position * Oxygen desaturation index with device on vs. off * Arousal index with device on vs. off * Duration of snoring with device on vs. off * Epworth Sleepiness Scale

Patient acceptance, in terms of:

* Refusal rate at screening * Discontinuation rate during follow-up * Daily compliance rate * Device-related adverse events * Serious adverse events

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Key information

Conditions

Obstructive Sleep Apnea Hypopnea Apnea Dyssomnias Nervous System Diseases OSA OSAH Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pulmonary Associates, Glendale, Arizona, United States

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About this study

Please see summary above

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 18 years
  • Diagnosis of OSA
  • AHI > 10 on diagnostic PSG performed within last 3 months
  • Investigator believes that subject can benefit from OSA tx
  • Subject understands and is willing and able to comply with study requirements

Exclusion criteria

  • Use of any device that interferes with nasal/oral breathing
  • Persistent blockage of one or both nostrils
  • Any chronic sores or lesions on the inside/outside of the nose
  • Chronic use of nasal decongestants other than nasal steroids
  • Oxygen saturation < 75% for > 10% of the diag. PSG
  • Oxygen saturation < 75% for > 25% of the first 4 hours of the diag. PSG
  • Prior or near-miss motor vehicle accident due to sleepiness (last 12 mo.)
  • Current use of hypnotics, anxiolytics, sedating antidepressants, anticonvulsants, sedating antihistamines, stimulants, or other medications likely to affect neurocognitive function and/or alertness
  • History of allergic reaction to acrylic-based adhesives
  • Current acute upper respiratory inflammation/infection or perforation of the tympanic membrane
  • History of frequent and/or poorly treated severe nasal allergies or sinusitis
  • Narcolepsy, idiopathic hypersomnolence, chronic insomnia, RLS, REM sleep behavior disorder or any other diagnosed or suspected sleep disorder
  • Current use of diurnal or nocturnal supplemental oxygen
  • History of CPAP use in the home for OSA tx
  • History of use of oral appliances for OSA tx
  • History of prior surgery for OSA
  • Currently working night or rotating shifts
  • Consumption of > 10 caffeinated beverages per day
  • History of severe cardiovasc. disease, including NYHA Class III or IV heart failure, CAD with angina or MI/stroke in past 6 months
  • History of cardiac rhythm disturbance
  • Uncontrolled hypertension (SBP > 180 or DBP > 105 mm Hg)
  • Uncontrolled hypotension(SBP < 80 or DBP < 55 mm Hg
  • History of severe respiratory disorders or unstable respiratory disease
  • Any other serious, uncontrolled medical condition
  • Females of child bearing age who are pregnant or intending to become pregnant
  • Consumes more than 3 drinks of alcohol/day
  • Chronic neurologic disorders
  • Cancer, unless in remission for more than 1 year
  • Current psychiatric illness
  • Smokers whose habit interferes with the overnight PSG
  • Any known illicit drug usage

Treatment and study plan

Provent Professional Sleep Apnea Therapy Device

Device

Application of active device (Provent)

Other names: Provent

Sham device

Device

Sham device will be applied

Primary outcomes

  1. Comparison of difference in AHI at one-week in-lab polysomnography between "device on" and "device off" nights, controlling for sleep position (supine vs. non-supine)

    Time frame: 3 months

Secondary outcomes

  1. Reduction in AHI, Oxygen desat index, Arousal index & Duration of snoring w/ device on/off;ESS,Patient acceptance,Device-related AEs & SAEs

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Ventus Medical, Inc.

Industry

Registry information

Official study title

Randomized, Double-blind Study to Compare Safety and Effectiveness of the ProventTM Professional Sleep Apnea Therapy Device to Sham for the Non-invasive Treatment of OSAH

Acronym: AERO

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 15, 2008
Registry last updated
Apr 1, 2010

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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