A Trial to Evaluate a Device for the Treatment of OSA and Snoring
NCT ID: NCT01772017
Last Updated: 2015-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
15 participants
INTERVENTIONAL
2012-10-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Device Treatment
Tongue Advancement Retainer Device
Tongue Advancement Retainer Device
Tongue Advancement Retainer Device
Interventions
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Tongue Advancement Retainer Device
Tongue Advancement Retainer Device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* AHI greater than or equal to 10 but less than or equal to 60 (\<10 AHI \<60/hr)
* Complete set of lower anterior incisors with no evidence of periodontal disease or mobility and the ability to floss between teeth
Additionally subjects will in the screening phase must:
* Tolerate the device when being fitted
* Used the device for \>4 hours on at least two consecutive nights during the screening period.
* Be able to reliably demonstrate proper installation of the device after fitting.
* Be willing to trial the device for a 4 week period
Exclusion Criteria
* Evidence of Cheyne stokes breathing
* Currently on treatment for OSA or OSA treatment discontinued less than 3 months prior.
* Currently on regular treatment with prescription hypnosedatives or prescription stimulants
* Very severe OSA, defined as AHI\>60/hour and/or minimum oxygen saturation \<75%
* Need for immediate initiation of treatment as assessed by physician (e.g. Excessive sleepiness posing driving risk)
* Previous surgery to treat OSA (other than nasal surgery)
* Evidence of periodontal disease or tooth mobility
* Severe nasal obstruction or enlarged tonsils based on clinical assessment
* Unstable cardiovascular disease (untreated hypertension acceptable).
* Inability to tolerate oral device due to oral condition or claustrophobia as determined by the study investigator
* Pregnant/Breast Feeding
* Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as co-existent other sleep disorder, psychiatric disease, history of non compliance to medical regimens, or unwillingness to comply with study requirements.
18 Years
65 Years
ALL
No
Sponsors
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Sleepy, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Brian Weeks, MD
Role: PRINCIPAL_INVESTIGATOR
Senta Clinic
Locations
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Senta Clinic
San Diego, California, United States
Visalia Medical Clinic
Visalia, California, United States
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Countries
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Other Identifiers
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OPEN-002
Identifier Type: -
Identifier Source: org_study_id