Home-based Under Mattress Monitor for OSA
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorIsabel Moreno Hay
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Diagnosis of central or mixed sleep apnea.
Neurocognitive disease.
Concomitant therapy with PAP therapy.
Allergic to the appliance material (Polyamide 12).
Trial design
Design model
Single group
Treatments tested in this trial
Under-mattress monitor
Devicethe 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
level 3 Home Sleep Apnea Test
DeviceHome 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.
Mandibular Advancement Device (MAD)
DeviceCAD-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
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: Panthera DSAD mandibular advancement device usersExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Change 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)2
Change in minimum oxygen desaturation level
The minimum O2 level percentage during treatment
Time frame
Baseline and post-intervention (approximately 12 weeks)Secondary outcomes
1
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)2
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)3
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)4
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.
Time frame
Baseline and post-intervention (approximately 12 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Isabel Moreno Hay
Lead sponsor
University of Kentucky
Sponsor institution
American Academy of Dental Sleep Medicine
Collaborator
Source ClinicalTrials.gov