Obstructive Sleep Apnea (OSAS), Obstructive Sleep Apnea (SAOS)
Conditions
Keywords
Mandibular Advancement, Sleep Apnea, Oral Appliance, Home-based, Obstructive Sleep Apnea, Home-based device
Brief summary
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.
Interventions
DEVICEUnder-mattress monitor
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
DEVICElevel 3 Home Sleep Apnea Test
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
Sponsors
Isabel Moreno Hay
American Academy of Dental Sleep Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Obstructive Sleep Apnea demonstrated with a sleep study polysomnography or home sleep study (PSG or HSAT), manually scored by a sleep physician according to the 2017 American Academy of Sleep medicine scoring guidelines. * Willingness to commute to the OFP clinic every 2 weeks during MAD titration period. * Consent to partake in the study.
Exclusion criteria
* Diagnosis of central or mixed sleep apnea. * Neurocognitive disease. * Concomitant therapy with PAP therapy. * Allergic to the appliance material (Polyamide 12). * Presence of active dental decay, ill-fitting dental restorations, or crown to root ratio unfavorable. * Inadequate English language comprehension. * Lack of coordination or dexterity to insert/remove the MAD intraorally. * Inability to tolerate digital dental impressions. * Patients with concomitant diagnosed sleep disorders, including narcolepsy, restless leg syndrome, rapid eye movement sleep behavior disorder).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in apnea-hypopnea index (AHI). | Baseline and post-intervention (approximately 12 weeks) | 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) |
| Change in minimum oxygen desaturation level | Baseline and post-intervention (approximately 12 weeks) | The minimum O2 level percentage during treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Epworth Sleepiness Scale | Baseline and post-intervention (approximately 12 weeks) | This scale measures daytime sleepiness. Scores range from 0-24. Higher scores indicate more severe daytime sleepiness. |
| Change in Quality of Life Scale | Baseline and post-intervention (approximately 12 weeks) | 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. |
| Change in Fatigue Assessment Scale | Baseline and post-intervention (approximately 12 weeks) | 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. |
| Change in Pittsburgh Sleep Quality Index (PSQI) | Baseline and post-intervention (approximately 12 weeks) | 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. |
| Change in Snore Outcomes Survey (SOS) | Baseline and post-intervention (approximately 12 weeks) | 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. |
| Short Assessment of Patient Satisfaction | Post Intervention, approximately week 12 | 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. |
Countries
United States
Contacts
CONTACTSumia Alyousef, BDS
PRINCIPAL_INVESTIGATORIsabel Moreno Hay, DDS, PhD
University of Kentucky
Outcome results
None listed