Treatment Sleep Bruxism With the Luco Hybrid OSA Appliance

NCT02882880 | Completed

• 1 other identifier: Lucohybridosa
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Bruxism; Tension Headache; Migraine Headache

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Started

OTHER

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

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

Device: The Luco Hybrid OSA Appliance

Interventions

The Luco Hybrid OSA Appliance DEVICE

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).

Also known as: Mandibular advancement appliance

Completed; Started

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Luco Hybrid OSA Appliance Inc.: lead

Study Sites (1)

Dr. K. Luco Dentistry Professional Corporation

Kingston, Ontario, K7L 0C3, Canada

Location

Related Publications (55)

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  PMID: 24235894 RESULT

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MeSH Terms

Conditions

Sleep Bruxism; Tension-Type Headache; Migraine Disorders

Condition Hierarchy (Ancestors)

Bruxism; Tooth Diseases; Stomatognathic Diseases; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases

Study Officials

• Ken J Luco, DDS, BSc

  Luco Hybrid OSA Appliance Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2016
• First Posted: August 30, 2016
• Study Start: July 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: February 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)