Mandibular advancement device (MAD) therapy in edentulous patients with obstructive sleep apnea: dental implant retained MAD therapy

Mandibular advancement device (MAD) therapy in edentulous patients with obstructive sleep apnea: dental implant retained MAD therapy - MADE study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47940

Enrollment

Registered

2019-09-25

Start date

2021-03-18

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive sleep apnea syndrome sleep apnea

Interventions

Mandibular Advancement Device (MAD) therapy

MAD retained on upper and lower overdentures fixed with 2 mandibular dental implants (or pre-existing dental implants). In case of overdenture related complaints during the MAD treatment work-up (e

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Male of female - Age 18 - 75 years - Sufficient understanding of Dutch language in speaking and writing. - Completely (mandibular and maxillary) edentate with or without dental implants - Diagnosed with moderate OSA (AHI between 15 - 30) or unsuccessfully treated with CPAP with moderate or severe OSA (AHI > 15) - No previous OSA therapy, except CPAP

Exclusion criteria

Exclusion criteria: Craniofacial deformities - Medication use related to a sleeping disorder - Evidence of respiratory/sleep disorders other than OSA (eg. central sleep apnea syndrome). - Reversible morphological upper airway abnormalities (e.g. enlarged tonsils). - Temporomandibular disorders

Design outcomes

Primary

Measure	Time frame
AHI (baseline vs. 3 months): apnea hypopnea Index (AHI) derived from standardized polysomnography studies at baseline and 3 months after CPAP treatment initiation (control-group) or MAD therapy initiation (intervention group).	—

Secondary

Measure	Time frame
- AHI (baseline vs. 12 months): apnea hypopnea Index (AHI) derived from standardized polysomnography studies at baseline and 12 months after CPAP treatment initiation (control-group) or MAD therapy initiation (intervention group). - Polysomnography parameters: These parameters include apnoea index (AI), hypopnoea index (HI), desaturation index (DI), snoring index (SI), lowest and mean oxygen saturation (SaO2) and sleep efficiency at baseline, 3 and 12 months after treatment initiation. - Functionality of the dentition and jaws: Functionality of the dentition and jaws will be assessed with the standardized MFIQ (Mandibular Function Impairment Questionnaire) questionnaire at baseline, 3 and 12 months after treatment initiation. - Sleep health and daily functioning: Sleep health and daily functioning will be assessed with the standardized ESS (Epworth Sleepiness Scale) questionnaire at baseline, 3 and 12 months after treatment initiation. - Therapy compliance: Patient compliance will be evaluated with a chip integrated in the MADs (monitoring total wearing time with temperature sensors) or monitored by the CPAP devices. A multi-week average compliance (% wearing time >4 hours per night) will be measured at the time period of 3 and 12 months after treatment initiation. - Quality of life (QoL): QoL will be measured with the standardized FOSQ-questionnaire at baseline, 3 and 12 months after treatment initiation.	—

Measure

Time frame

- AHI (baseline vs. 12 months): apnea hypopnea Index (AHI) derived from standardized polysomnography studies at baseline and 12 months after CPAP treatment initiation (control-group) or MAD therapy initiation (intervention group). - Polysomnography parameters: These parameters include apnoea index (AI), hypopnoea index (HI), desaturation index (DI), snoring index (SI), lowest and mean oxygen saturation (SaO2) and sleep efficiency at baseline, 3 and 12 months after treatment initiation. - Functionality of the dentition and jaws: Functionality of the dentition and jaws will be assessed with the standardized MFIQ (Mandibular Function Impairment Questionnaire) questionnaire at baseline, 3 and 12 months after treatment initiation. - Sleep health and daily functioning: Sleep health and daily functioning will be assessed with the standardized ESS (Epworth Sleepiness Scale) questionnaire at baseline, 3 and 12 months after treatment initiation. - Therapy compliance: Patient compliance will be evaluated with a chip integrated in the MADs (monitoring total wearing time with temperature sensors) or monitored by the CPAP devices. A multi-week average compliance (% wearing time >4 hours per night) will be measured at the time period of 3 and 12 months after treatment initiation. - Quality of life (QoL): QoL will be measured with the standardized FOSQ-questionnaire at baseline, 3 and 12 months after treatment initiation.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)