Treatment Sleep Bruxism With the Luco Hybrid OSA Appliance

Study Overview
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Brief Summary
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To determine the effectiveness of the Luco Hybrid OSA Appliance in the treatment of sleep bruxism and to aid in the treatment of associated tension/migraine type headaches in adults.

Detailed Description
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51 subjects were selected and separated into two groups: those new to the treatment (Group 1)and those who had been in treatment for more than 1 year (Group 2). There were 32 participants in group 1 and 19 in group 2. mean age for Group 1 was 41.7 and Group 2 was 50.5. The age range for Group 1 was 21 to 66 and in Group 2 34 to 73. Group 1 subjects were fitted with a Luco hybrid OSA appliance (LHOA). They were followed over a 14 day period with adjustments made to the device as required. The second study [milestone] was completed at that time. Group 2 subjects, who had previously been in treatment with the device for and mean of 4.1 years, had an initial study with the device and a second study following 48 hours without the device. Both groups were studied again at 60 days and results compared.

Official Title
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The Treatment of Sleep Bruxism With the Luco Hybrid OSA Appliance

Conditions
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Sleep Bruxism, Tension Headache, Migraine Headache

Intervention / Treatment
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* Device: The Luco Hybrid OSA Appliance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age (adult) capable of giving informed consent met the AASM criteria for sleep bruxism had sound dentition did not have active obstructive sleep apnea(OSA)/upper airway resistance syndrome (UARS) Exclusion Criteria: younger than 18 incapable of informed consent did not meet the AASM criteria for sleep bruxism discovered OSA or UARS in the initial study did not have sound dentition (active caries, periodontal disease, inadequate number of teeth had obstructive sleep apnea/UARS did not complete the study completed the study but did not complete all aspects of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Started<br>Intervention: Treatment with the Luco Hybrid OSA Appliance (LHOA) Group 1, fitted with LHOA Group 2: LHOA removed for 48 hours | Device: The Luco Hybrid OSA Appliance<br>* Group 1, initial treatment with the device, reassessed at 14 and 60 days, Group 2, removal of the treatment for 48 hours, to determine if relapse occurs, retested at 60 days with the device (recovery from intervention).<br>* Other names: Mandibular advancement appliance;|
| Active Comparator: Completed<br>Intervention: The LUco Hybrid OSA APpliance The subjects that actually completed the study in both groups. Group 1 n = 32, in Group 2 n=19 | Device: The Luco Hybrid OSA Appliance<br>* Group 1, initial treatment with the device, reassessed at 14 and 60 days, Group 2, removal of the treatment for 48 hours, to determine if relapse occurs, retested at 60 days with the device (recovery from intervention).<br>* Other names: Mandibular advancement appliance;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to treatment with the Luco Hybrid OSA Appliance | Clinical examination, sleep study and visual analog scale. Clinical examination of the subject's musculature, temporomandibular joints (TMJ), and measurement of the range of mandibular movements. The home sleep study (HSS) measured the number and duration of sleep bruxism events as well as the heart rate associated with these events. The visual analog scale (VAS) recorded the patient's response regarding TMJ pain on waking and later in the day, jaw muscle pain on waking and later in the day, tooth sensitivity to temperature extremes, tension/migraine type headaches on waking and later in the day and neck/shoulder pain on waking and later in the day. HSS scoring according to the American Academy of Sleep Medicine's Manual for the Scoring of Sleep and Associated Events for sleep bruxism. | 60 days |