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Treatment Sleep Bruxism With the Luco Hybrid OSA Appliance (LucoHybrid)

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ClinicalTrials.gov Identifier: NCT02882880
Recruitment Status : Completed
First Posted : August 30, 2016
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Ken Luco, Luco Hybrid OSA Appliance Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sleep Bruxism Tension Headache Migraine Headache Device: The Luco Hybrid OSA Appliance Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Treatment of Sleep Bruxism With the Luco Hybrid OSA Appliance
Study Start Date : July 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Started
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
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).
Other Name: Mandibular advancement appliance

Active Comparator: Completed
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
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).
Other Name: Mandibular advancement appliance




Primary Outcome Measures :
  1. Response to treatment with the Luco Hybrid OSA Appliance [ Time Frame: 60 days ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02882880


Locations
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Canada, Ontario
Dr. K. Luco Dentistry Professional Corporation
Kingston, Ontario, Canada, K7L 0C3
Sponsors and Collaborators
Luco Hybrid OSA Appliance Inc.
Investigators
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Principal Investigator: Ken J Luco, DDS, BSc Luco Hybrid OSA Appliance Inc.

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: Study Protocol
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: Statistical Analysis Plan
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: Informed Consent
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: Study Report

Publications of Results:

Other Publications:

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Responsible Party: Dr. Ken Luco, Principal Investigator, Luco Hybrid OSA Appliance Inc.
ClinicalTrials.gov Identifier: NCT02882880     History of Changes
Other Study ID Numbers: Lucohybridosa
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: I wish to publish articles in the American Dental Association Journal and Sleep using this data.
Additional relevant MeSH terms:
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Bruxism
Sleep Bruxism
Migraine Disorders
Tension-Type Headache
Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tooth Diseases
Stomatognathic Diseases
Parasomnias
Sleep Wake Disorders
Mental Disorders