Sleep BruxismLucoHybridNCT02882880
Treatment Sleep Bruxism With the Luco Hybrid OSA Appliance
A study testing The Luco Hybrid OSA Appliance in people with Sleep Bruxism and Tension Headache, run by Luco Hybrid OSA Appliance Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Bruxism, Tension Headache, Migraine Headache
- What is being tested?
- The Luco Hybrid OSA Appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Dr. K. Luco Dentistry Professional Corporation
Kingston, Ontario, K7L 0C3
About this study
Official title: The Treatment of Sleep Bruxism With the Luco Hybrid OSA Appliance
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.
Read the 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.
- Conditions
- Sleep Bruxism, Tension Headache, Migraine Headache
- Being tested
- The Luco Hybrid OSA Appliance
- Medical subject headings
- Sleep Bruxism, Tension-Type Headache, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Luco Hybrid OSA ApplianceDevice
Also called Mandibular advancement 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).
| Study group | Role | What they receive |
|---|---|---|
| Started | Other | Intervention: Treatment with the Luco Hybrid OSA Appliance (LHOA) Group 1, fitted with LHOA Group 2: LHOA removed for 48 hours Receives: Device: The Luco Hybrid OSA Appliance |
| Completed | Active comparator | 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 Receives: Device: The Luco Hybrid OSA Appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startJul 2015
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (55)Papers the sponsor has linked to this study.
- Other trials for Sleep BruxismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luco Hybrid OSA Appliance Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Dr. Ken Luco, Luco Hybrid OSA Appliance Inc.
- Investigators
- Ken J Luco, DDS, BSc, Principal investigator, Luco Hybrid OSA Appliance Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882880
- Sponsor's protocol ID
- Lucohybridosa
- Acronym
- LucoHybrid
- Status last verified
- Feb 2021
- First submitted
- 21 Aug 2016
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Klasser GD, Greene CS, Lavigne GJ. Oral appliances and the management of sleep bruxism in adults: a century of clinical applications and search for mechanisms. Int J Prosthodont. 2010 Sep-Oct;23(5):453-62.
PubMed 20859563Raphael KG, Santiago V, Lobbezoo F. Is bruxism a disorder or a behaviour? Rethinking the international consensus on defining and grading of bruxism. J Oral Rehabil. 2016 Oct;43(10):791-8. doi: 10.1111/joor.12413. Epub 2016 Jun 10.
PubMed 27283599Tavares LM, da Silva Parente Macedo LC, Duarte CM, de Goffredo Filho GS, de Souza Tesch R. Cross-sectional study of anxiety symptoms and self-report of awake and sleep bruxism in female TMD patients. Cranio. 2016 Nov;34(6):378-381. doi: 10.1080/08869634.2016.1163806. Epub 2016 Apr 20.
PubMed 27097685Gomes CAFP, El-Hage Y, Amaral AP, Herpich CM, Politti F, Kalil-Bussadori S, Gonzalez TO, Biasotto-Gonzalez DA. Effects of Massage Therapy and Occlusal Splint Usage on Quality of Life and Pain in Individuals with Sleep Bruxism: A Randomized Controlled Trial. J Jpn Phys Ther Assoc. 2015;18(1):1-6. doi: 10.1298/jjpta.Vol18_001.
PubMed 26733760Dharmadhikari S, Romito LM, Dzemidzic M, Dydak U, Xu J, Bodkin CL, Manchanda S, Byrd KE. GABA and glutamate levels in occlusal splint-wearing males with possible bruxism. Arch Oral Biol. 2015 Jul;60(7):1021-9. doi: 10.1016/j.archoralbio.2015.03.006. Epub 2015 Mar 28.
PubMed 25889171Hesselbacher S, Subramanian S, Rao S, Casturi L, Surani S. Self-reported sleep bruxism and nocturnal gastroesophageal reflux disease in patients with obstructive sleep apnea: relationship to gender and ethnicity. Open Respir Med J. 2014 Oct 22;8:34-40. doi: 10.2174/1874306401408010034. eCollection 2014.
PubMed 25352924Carra MC, Huynh N, Fleury B, Lavigne G. Overview on Sleep Bruxism for Sleep Medicine Clinicians. Sleep Med Clin. 2015 Sep;10(3):375-84, xvi. doi: 10.1016/j.jsmc.2015.05.005. Epub 2015 Jul 8.
PubMed 26329448Mayer P, Heinzer R, Lavigne G. Sleep Bruxism in Respiratory Medicine Practice. Chest. 2016 Jan;149(1):262-71. doi: 10.1378/chest.15-0822. Epub 2016 Jan 6.
PubMed 26225899Klasser GD, Rei N, Lavigne GJ. Sleep bruxism etiology: the evolution of a changing paradigm. J Can Dent Assoc. 2015;81:f2.
PubMed 25633110Saito M, Yamaguchi T, Mikami S, Watanabe K, Gotouda A, Okada K, Hishikawa R, Shibuya E, Lavigne G. Temporal association between sleep apnea-hypopnea and sleep bruxism events. J Sleep Res. 2013 Nov 4. doi: 10.1111/jsr.12099. Online ahead of print.
PubMed 24635459Hasegawa Y, Lavigne G, Rompre P, Kato T, Urade M, Huynh N. Is there a first night effect on sleep bruxism? A sleep laboratory study. J Clin Sleep Med. 2013 Nov 15;9(11):1139-45. doi: 10.5664/jcsm.3152.
PubMed 24235894Abe S, Gagnon JF, Montplaisir JY, Postuma RB, Rompre PH, Huynh NT, Kato T, Kawano F, Lavigne GJ. Sleep bruxism and oromandibular myoclonus in rapid eye movement sleep behavior disorder: a preliminary report. Sleep Med. 2013 Oct;14(10):1024-30. doi: 10.1016/j.sleep.2013.04.021. Epub 2013 Aug 15.
PubMed 23953215Raphael KG, Sirois DA, Janal MN, Wigren PE, Dubrovsky B, Nemelivsky LV, Klausner JJ, Krieger AC, Lavigne GJ. Sleep bruxism and myofascial temporomandibular disorders: a laboratory-based polysomnographic investigation. J Am Dent Assoc. 2012 Nov;143(11):1223-31. doi: 10.14219/jada.archive.2012.0068.
PubMed 23115152Carra MC, Huynh N, Lavigne G. Sleep bruxism: a comprehensive overview for the dental clinician interested in sleep medicine. Dent Clin North Am. 2012 Apr;56(2):387-413. doi: 10.1016/j.cden.2012.01.003.
PubMed 22480810Nashed A, Lanfranchi P, Rompre P, Carra MC, Mayer P, Colombo R, Huynh N, Lavigne G. Sleep bruxism is associated with a rise in arterial blood pressure. Sleep. 2012 Apr 1;35(4):529-36. doi: 10.5665/sleep.1740.
PubMed 22467991
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of Sleep Bruxism With the Luco Hybrid OSA Appliance
- ClinicalTrials.gov ID
- NCT02882880
- Acronym / sponsor ID
- LucoHybrid / Lucohybridosa
- Conditions
- Sleep Bruxism, Tension Headache, Migraine Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Luco Hybrid OSA Appliance Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Started | Other | Device: The Luco Hybrid OSA ApplianceIntervention: Treatment with the Luco Hybrid OSA Appliance (LHOA) Group 1, fitted with LHOA Group 2: LHOA removed for 48 hours |
| Completed | Active comparator | Device: The Luco Hybrid OSA ApplianceIntervention: The LUco Hybrid OSA APpliance The subjects that actually completed the study in both groups. Group 1 n = 32, in Group 2 n=19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Luco Hybrid OSA ApplianceAlso: Mandibular advancement applianceGroup 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). | Device | Completed, Started |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Background: PubMed 20859563Klasser GD, Greene CS, Lavigne GJ. Oral appliances and the management of sleep bruxism in adults: a century of clinical applications and search for mechanisms. Int J Prosthodont. 2010 Sep-Oct;23(5):453-62.
- Background: PubMed 27283599Raphael KG, Santiago V, Lobbezoo F. Is bruxism a disorder or a behaviour? Rethinking the international consensus on defining and grading of bruxism. J Oral Rehabil. 2016 Oct;43(10):791-8. doi: 10.1111/joor.12413. Epub 2016 Jun 10.
- Background: PubMed 27097685Tavares LM, da Silva Parente Macedo LC, Duarte CM, de Goffredo Filho GS, de Souza Tesch R. Cross-sectional study of anxiety symptoms and self-report of awake and sleep bruxism in female TMD patients. Cranio. 2016 Nov;34(6):378-381. doi: 10.1080/08869634.2016.1163806. Epub 2016 Apr 20.
- Background: PubMed 26733760Gomes CAFP, El-Hage Y, Amaral AP, Herpich CM, Politti F, Kalil-Bussadori S, Gonzalez TO, Biasotto-Gonzalez DA. Effects of Massage Therapy and Occlusal Splint Usage on Quality of Life and Pain in Individuals with Sleep Bruxism: A Randomized Controlled Trial. J Jpn Phys Ther Assoc. 2015;18(1):1-6. doi: 10.1298/jjpta.Vol18_001.
- Background: PubMed 25889171Dharmadhikari S, Romito LM, Dzemidzic M, Dydak U, Xu J, Bodkin CL, Manchanda S, Byrd KE. GABA and glutamate levels in occlusal splint-wearing males with possible bruxism. Arch Oral Biol. 2015 Jul;60(7):1021-9. doi: 10.1016/j.archoralbio.2015.03.006. Epub 2015 Mar 28.
- Background: PubMed 25352924Hesselbacher S, Subramanian S, Rao S, Casturi L, Surani S. Self-reported sleep bruxism and nocturnal gastroesophageal reflux disease in patients with obstructive sleep apnea: relationship to gender and ethnicity. Open Respir Med J. 2014 Oct 22;8:34-40. doi: 10.2174/1874306401408010034. eCollection 2014.
- Results publication: PubMed 26329448Carra MC, Huynh N, Fleury B, Lavigne G. Overview on Sleep Bruxism for Sleep Medicine Clinicians. Sleep Med Clin. 2015 Sep;10(3):375-84, xvi. doi: 10.1016/j.jsmc.2015.05.005. Epub 2015 Jul 8.
- Results publication: PubMed 26225899Mayer P, Heinzer R, Lavigne G. Sleep Bruxism in Respiratory Medicine Practice. Chest. 2016 Jan;149(1):262-71. doi: 10.1378/chest.15-0822. Epub 2016 Jan 6.
- Results publication: PubMed 25633110Klasser GD, Rei N, Lavigne GJ. Sleep bruxism etiology: the evolution of a changing paradigm. J Can Dent Assoc. 2015;81:f2.
- Results publication: PubMed 24635459Saito M, Yamaguchi T, Mikami S, Watanabe K, Gotouda A, Okada K, Hishikawa R, Shibuya E, Lavigne G. Temporal association between sleep apnea-hypopnea and sleep bruxism events. J Sleep Res. 2013 Nov 4. doi: 10.1111/jsr.12099. Online ahead of print.
- Results publication: PubMed 24235894Hasegawa Y, Lavigne G, Rompre P, Kato T, Urade M, Huynh N. Is there a first night effect on sleep bruxism? A sleep laboratory study. J Clin Sleep Med. 2013 Nov 15;9(11):1139-45. doi: 10.5664/jcsm.3152.
- Results publication: PubMed 23953215Abe S, Gagnon JF, Montplaisir JY, Postuma RB, Rompre PH, Huynh NT, Kato T, Kawano F, Lavigne GJ. Sleep bruxism and oromandibular myoclonus in rapid eye movement sleep behavior disorder: a preliminary report. Sleep Med. 2013 Oct;14(10):1024-30. doi: 10.1016/j.sleep.2013.04.021. Epub 2013 Aug 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ken J Luco, DDS, BSc principal investigator
Luco Hybrid OSA Appliance Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Luco Hybrid OSA Appliance in people with Sleep Bruxism and Tension Headache, run by Luco Hybrid OSA Appliance Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to treatment with the Luco Hybrid OSA Appliance (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02882880, which also lists 55 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.