Efficacy of Additional Titration During Oral Appliance Treatment for Sleep-disordered Breathing.

Obstructive Sleep Apnea Syndrome Clinical Trial

Official title:

Efficacy of Additional Titration During Oral Appliance Treatment for Sleep-disordered Breathing.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01666886
• Other study ID #: EC 12/30/243
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: April 2015

Study information

• Verified date: January 2021
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the protocol "Predicting therapeutic outcome of mandibular advancement device treatment in obstructive sleep apnea (PROMAD)", 100 patients with obstructive sleep apnea are included and started MAD treatment at 75% of maximal protrusion. All patients underwent polysomnography with MAD in situ to evaluate the effect of the MAD on severity of sleep apnea. If the results of the polysomnography with MAD are unsuccessful (defined as a reduction in AHI with the MAD in situ of less than 50% compared to baseline), the therapy needs to be adjusted. Finding the most effective protrusion should be a weighted compromise between efficacy and side-effects of MAD therapy.

In patients with insufficient results on the polysomnography with the MAD at 75% of maximal protrusion, the MAD will be further adjusted until 90% of the maximal protrusion measured at the follow-up visit after the polysomnography with the MAD. After habituation and adaptation period but within 2 months after the first polysomnography with MAD, a new polysomnography will be performed to assess the effect of the 90% protruded position.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Body Mass Index (BMI) = 35 kg/m²

• OSAS, as defined by the American Academy of Sleep Medicine Task Force

• apnea-hypopnea index (AHI) < 50

• incomplete elimination of apneas and/or hypopnea during therapy with mandibular advancement device in 75% of maximal protrusion

Exclusion Criteria:

• Other sleep disorders (i.e. parasomnias)

• Invasive upper airway surgery for sleep-disordered breathing

• Known genetic disorders with craniofacial and/or upper airway malformations

• Use of benzodiazepine and/or antidepressants

• Known history of psychiatric disease

• Known history of fibromyalgia and/or chronic fatigue syndrome

• Dental contra-indications: functional restrictions of the temporomandibular joint, insufficient dentition with pathological changes, insufficient retention for MAD use

Related Conditions & MeSH terms

• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Mandibular Advancement Device (MAD)

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Wilrijk	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polysomnographic efficacy	Polysomnographic re-evaluation of the severity of sleep apnea (apnea/hypopnea index).	3 to 6 months after start of therapy