Nocturia, Obstructive Sleep Apnea, OSA
Conditions
Keywords
obstructive sleep apnea, oral appliance, nocturia, mandibular advancement device
Brief summary
The main purpose of this study is to test is mandibular advancement device (MAD) use is associated with reductions in nocturia.
Detailed description
After been informed about the study and informed about risks and benefits, participants will be fitted with a MAD and will be asked to completed questionnaires at baseline, in between follow ups and during follow ups. Nocturia will be assess and appliance will be titrated every 2 weeks until participants report less than 2 voiding per night according to the daily dairies. At that point, second sleep study with MAD in place will be performed to assess treatment effectiveness.
Interventions
DEVICESomnodent Classic
The efficacy of the device will be evaluated in regards to the response of nocturia. Once patients report an average of voiding per night of less than 2 in the preceding 2 weeks of the follow up they will be classified as responders in term of nocturia and will be evaluated with a second sleep study. Efficacy of MAD will be assessed by comparing the apnea hypopnea index (AHI) values of pre and post sleep study with MAD, and they will be classified as responders if they have 50% improvement in AHI.
Sponsors
Isabel Moreno Hay
American Academy of Dental Sleep Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Uncontrolled open label clinical trial. Data gathers from recruitment until appliance delivery will be used allowing each participant to also be their own control, as wait list type of study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* English speaker * \>18 y/o * Obstructive sleep apnea diagnosis with AHI≥5 * ≥ 2 voiding/night at baseline * Upon clinical examination ≥ 8 teeth per arch, range of mandibular protrusion ≥5 mm * Consent to participate in the study.
Exclusion criteria
* Patients with concomitant diagnosed sleep disorders (i.e. insomnia, narcolepsy, restless legs syndrome, rapid eye movement sleep behavior disorder). * Prostate/kidney problems (urological disease: (eg overactive bladder, benign prostate hyperplasia) * Pregnancy * Heart failure, use of diuretics, diabetes, Parkinson's disease or dementia. * Patients using combination therapy for the management of obstructive sleep apnea (OSA) (i.e. positive airway pressure (PAP) therapy or positional therapy). * Upon clinical examination: periodontal disease (\>4 mm on periodontal probing, with bleeding on probing, visual signs of periodontal inflammation); tooth horizontal mobility \>1 mm, vertical mobility, and unfavorable crown to root ratio; open cavities, loose or fractured restorations, or patient undergoing restorative dental treatments. * Exaggerated gag reflex. * Lack of coordination or dexterity. * Inadequate English comprehension.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Test MAD if Associated in Changes in Nocturia | 15 weeks | Assessment of efficacy of device in terms of nocturia: Patients will complete daily questionnaires to evaluate voiding at night. Average of 2 preceding weeks of the follow up will be used to determine treatment success in terms of nocturia. Once less than 2 voiding's per night is achieved participants will be considers responders in terms of nocturia and second sleep study will be performed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Association Between Change in Nocturia Episodes and Change in Apnea-Hypopnea Index (API) | 15 weeks | Pearson Correlation Coefficient between the change in Baseline to Week 15 in average nightly nocturia episodes and the change from Baseline to Week 15 in Apnea-Hypopnea Index (API) following mandibular advancement device therapy. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORFernanda Yanez Regonesi, DDS, MS
University Of Kentucy
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 50.36 years STANDARD_DEVIATION 12.86 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
None listed