Study of a Sleep Apnea System for the Treatment of Obstructive Sleep Apnea

NCT01146782 | Completed Results

• 1 other identifier: 10753
• Study Type: interventional
• Target: 367
• Locations: 1 country
• Sites: 6

Brief Summary

This is a prospective study of the Attune Sleep Apnea System for the treatment of obstructive sleep apnea. The objective of the study is to demonstrate safety and effectiveness of the Attune Sleep Apnea System to support FDA marketing clearance of the device.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Clinical Success Defined as Apnea-hypopnea Index (AHI) Reduction of >50% and Treated AHI<20

  Comparing first treatment night AHI to control/baseline night. AHI is calculated by dividing the number of apnea/hypopnea events by the number of hours of sleep. AHI values are typically characterized as 5-15/hr = mild OSA, 15-30/hr = moderate OSA, and \>30/hr = severe OSA. For each subject, Clinical success was defined as apnea-hypopnea index (AHI) reduction of \>50% and treated AHI\<20. The number of subjects with clinical success was determined to calculate the primary endpoint as the ratio of the number of subjects with clinical success to the number of subjects.

  first treatment night

Secondary Outcomes (3)

• Adverse Event Rate

  4 weeks

• Last Treatment Night Response (AHI Reduction)

  At completion of 28 day home use.

• Percent Reduction in Oxygen Desaturation Index (ODI)

  First treatment night

Study Arms (1)

Treatment

EXPERIMENTAL

Treatment with the Attune Sleep Apnea System

Device: Attune Sleep Apnea System

Interventions

Attune Sleep Apnea System DEVICE

Console and mouthpiece sleep apnea system

Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is between the ages of 18 and 80.
• Diagnosis of OSA, based on ODI 10-60 (as assessed per home screening night).
• Subject is fluent in English and understands the Study protocol and is willing and able to comply with Study requirements and sign the informed consent form.
• BMI \< 40.
• Subject has a least one molar in each of the four quadrants of the mouth (right upper, right lower, left upper, and left lower).
• Subject has proper mouthpiece fit, as assessed by home screening night (See section 8.3).

You may not qualify if:

• OSA treatment within two weeks prior to Medical/Dental screening visit.
• Poor nasal patency as evidenced by Peak Nasal Inspiratory Flow (PNIF) less than 75 l/min (assessed at baseline medical visit). In addition, any ongoing process or condition that limits nasal breathing or indications thereof, including: obligate mouth-breathing, persistent blockage of one or both nostrils resulting in the inability to sleep with the mouth closed, chronic nasal congestion, chronic allergic rhinitis, and intermittent allergic rhinitis that does not respond to non-sedating/non-stimulating medical therapy.
• Oral cavity infection or any other oral or dental condition or problem that would limit subject use of the Attune Sleep Apnea System (e.g. dentures, loose tooth/teeth, temporomandibular joint (TMJ) conditions, or any oral or dental condition that the Investigator believes could be exacerbated by the Attune Sleep Apnea System.
• Prior use of the Attune Sleep Apnea System.
• History of any OSA surgical treatment including uvulopalatopharyngoplasty surgery (UPPP), maxillomandibular advancement surgery (MMA), radio frequency (RF) ablation treatment, palatal stent devices, etc.
• Current use or use within the previous 2 weeks of medications or other agents that may affect sleep or PSG, including:
• Hypnotics, anxiolytics, anticonvulsants, sedating antihistamines, stimulants, sedating antidepressants or other medications likely to affect neurocognitive function and/or alertness. Patients on stable selective serotonin reuptake inhibitor (SSRI) therapy for \> 3 months and who are expected to remain on therapy for the Study duration, may continue SSRI treatment.
• Consumption of \> 500mg caffeine per day (e.g. \> 8 cola-type beverages, \> 5 cups of coffee).
• Any known illicit drug use or abuse within the past year, or failure to pass drug urine screen test, or alcohol breathalyzer test with result over 0.05% BAL.
• Smokers who smoke during the night (interference with PSG).
• Any concomitant diagnosed or suspected sleep or chronic neurological disorders, other than OSA, including insomnia, and central sleep apnea.
• Currently working nights, rotating night shifts, planned travel across four or more time zones required during Study period, or within two weeks prior to Study enrollment, or sleep schedule not compatible with sleep lab practices.
• Potential sleep apnea complications that, in the opinion of the investigator, may affect the health or safety of the participant, including: low blood oxygen, recent near-miss or prior automobile accident due to sleepiness, reported history of severe cardiovascular disease (including NYHA class III or IV heart failure, CAD with angina or MI/stroke in past 6 months, uncontrolled hypertension or hypotension, cardiac arrhythmias), reported respiratory disorders, or use of medication or other treatment which may pose additional risk to the subject or confound the results of the Study.
• Female subjects who are pregnant or intend to become pregnant during the study period.

Sponsors & Collaborators

• ApniCure, Inc.: lead

Study Sites (6)

REM Medical

Phoenix, Arizona, 85037, United States

Location

Peninsula Sleep Center

Burlingame, California, 94010, United States

Location

SRI

Menlo Park, California, 94025, United States

Location

Sleep Disorders Center of Georgia (SDCG)

Atlanta, Georgia, 30342, United States

Location

SleepMed

Columbia, South Carolina, 29201, United States

Location

Sleep Medicine Associates of Texas (SMAT)

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Andrea Brown, Director, Clinical Affairs
• Organization: ApniCure, Inc.

abrown@apnicure.com

650-361-9000

Study Officials

• Ian Colrain, PhD

  Stanford Reasearch Institute (SRI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2010
• First Posted: June 22, 2010
• Study Start: June 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: June 30, 2014
• Results First Posted: June 30, 2014

Record last verified: 2014-05

Locations

US (6)