The aim of the study is to evaluate the effectiveness of the under-mattress monitoring device to aid in the titration process of a mandibular advancement device (MAD) for the management of obstructive sleep apnea (OSA). A secondary aim is to evaluate changes in subjective OSA symptoms and patient's satisfaction with MAD. A third aim is to analyze if there are differences between the sleep parameters recorded by the under-mattress monitor between responders and non-responders to MAD therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
70
the under-mattress monitor will be used in conjunction with the Alice NightOne at the beginning and end of the study, in addition, the under-mattress monitor will be used daily during sleep with the intraoral device in situ
Home sleep apnea test with Alice NightOne will be used for one day during sleep at the beginning and end of the study in conjunction with the Sleeptracker AI and the intraoral device.
CAD-CAM, US Food and Drug Administration (FDA)-approved MAD, duo-bloc, customized, titratable sleep appliance. Participants will return every 2 weeks to the Orofacial Pain (OFP) clinic to progressively titrate the MAD advancement as needed until the under-mattress monitor scores an AHI \< 5
University of Kentucky
Lexington, Kentucky, United States
RECRUITINGChange in apnea-hypopnea index (AHI).
Number of apneas and hypopneas per hour of sleep which is an indicator of severity of sleep apnea, (5\< normal, 5-15 Mild, 15-30 moderate, \<30 severe)
Time frame: Baseline and post-intervention (approximately 12 weeks)
Change in minimum oxygen desaturation level
The minimum O2 level percentage during treatment
Time frame: Baseline and post-intervention (approximately 12 weeks)
Change in Epworth Sleepiness Scale
This scale measures daytime sleepiness. Scores range from 0-24. Higher scores indicate more severe daytime sleepiness.
Time frame: Baseline and post-intervention (approximately 12 weeks)
Change in Quality of Life Scale
Quality of life (15D questionnaire) with 15 question items with 5 alternatives in each. The scores range between 15 to 75 with 15 the best and 75 the worst quality of life.
Time frame: Baseline and post-intervention (approximately 12 weeks)
Change in Fatigue Assessment Scale
The scale consists of 10 questions about the characteristics of fatigue in the current daily routine. The scale scores range from 10-50, with higher score indicating higher level of fatigue.
Time frame: Baseline and post-intervention (approximately 12 weeks)
Change in Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a 19-item questionnaire that includes seven areas of sleep quality and patterns in adults over the last month including the following components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, SDs, use of sleeping medications, and daytime dysfunction. Each item in the scale is scored from 0 to 3 scale (0 = no difficulty; 3 = severe difficulty). The scores are added to yield a global score ranging from 0 to 21 (0 = no difficulty; 21 = severe difficulties in all areas). A high total scale score indicates poor sleep quality.
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Time frame: Baseline and post-intervention (approximately 12 weeks)
Change in Snore Outcomes Survey (SOS)
SOS consists of eight items related to the frequency, duration, severity, and consequences associated with sleep-disordered breathing and specifically snoring. Respondents use several Likert-type scales to answer questions regarding their snoring, with lower scores indicating more acute problems with SDB. Scores are normalized on a scale from 0 to 100.
Time frame: Baseline and post-intervention (approximately 12 weeks)
Short Assessment of Patient Satisfaction
Patient satisfaction with MAD will be measured by a 7-item questionnaire scored on a Likert type scale. Scores range from 7 to 35. Higher scores equate to greater satisfaction.
Time frame: Post Intervention, approximately week 12