Treatment Sleep Bruxism With the Luco Hybrid OSA Appliance

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Styrktaraðilar

Luco Hybrid OSA Appliance Inc.

KLÍNÍSK RANNSÓKN: NCT02882880

BioSeek: nct02882880

Lykilorð

Útdráttur

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.

Lýsing

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.

Dagsetningar

Síðast staðfest:	07/31/2016
Fyrst lagt fram:	08/20/2016
Áætluð skráning lögð fram:	08/23/2016
Fyrst sent:	08/29/2016
Síðasta uppfærsla lögð fram:	08/23/2016
Síðasta uppfærsla sett upp:	08/29/2016
Raunverulegur upphafsdagur náms:	06/30/2015
Áætlaður aðallokunardagur:	05/31/2016
Áætlaður dagsetningu rannsóknar:	06/30/2016

Ástand eða sjúkdómur

Sleep Bruxism

Tension Headache

Migraine Headache

Íhlutun / meðferð

Device: The Luco Hybrid OSA Appliance

Stig

Armhópar

Armur	Íhlutun / meðferð
Other: Started Intervention: Treatment with the Luco Hybrid OSA Appliance (LHOA) Group 1, fitted with LHOA Group 2: LHOA removed for 48 hours
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

Hæfniskröfur

Aldur hæfur til náms	18 Years Til 18 Years
Kyn sem eru hæf til náms	All
Tekur við heilbrigðum sjálfboðaliðum	Já
Viðmið	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

Útkoma

Aðal niðurstöður ráðstafanir

1. Response to treatment with the Luco Hybrid OSA Appliance [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.