Oral Appliance in Obstructive Sleep Apnea. A Randomized Controlled Blinded Multicenter Study Comparing Two Devices

Obstructive Sleep Apnea Clinical Trial

Official title:

Oral Appliance in the Treatment of Obstructive Sleep Apnea. A Randomized Controlled Blinded Multicenter Study Comparing the Efficacy of Two Devices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02148510
• Other study ID #: Apnea-2
• Secondary ID: Ethical approval
• Status: Completed
• Phase: N/A
• First received: May 16, 2014
• Last updated: November 6, 2017
• Start date: May 2014
• Est. completion date: May 15, 2017

Study information

• Verified date: November 2017
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The hypothesis of the study is that a bibloc-apnea splint has a comparable efficacy on respiratory measures as a monobloc-apnea splint and that the cost of treatment is the same. The goal is primarily to compare the Apnea-Hypopnea Index (AHI) after 6 weeks of treatment and the cost of treatment during one year.

This randomized controlled parallel group multicenter study includes 316 subjects referred for the treatment of moderate to severe Obstructive Sleep Apnea (OSA). The subjects visit the clinic at 5 scheduled occasions.

Description:

The study includes 2 arms. Secondary measures are obtained by respiratory analysis and questionnaires. Electromyography (EMG) of the masseter muscle is recorded and the influence of bruxism is evaluated in terms effect on efficacy and adverse events

Recruitment information / eligibility

• Status: Completed
• Enrollment: 313
• Est. completion date: May 15, 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The diagnosis of obstructive sleep apnea with AHI > 15

• Odontological status that allows retention of oral devices and with at least one molar in each quadrant

• Maximal protrusion >6 mm

• Subject giving his/her informed concent

• Understands and can communicate in Swedish

• Subject understands the instruction on how to put on the polygraphy equipment at home

• Valid AHI data at baseline respiratory analysis

Exclusion Criteria:

• age< 18 år

• BMI >35

• Jaw complaints requiring treatment the past year

• Pain or locking of the jaw at the enrollment visit

• At the discretion of the investigator judged not being able to attach to the study directives

• Hypersensitive to the material of the devices

• Ongoing Continuous Positive Airway Pressure (CPAP) treatment or oral device treatment or such treatment terminated within a month from enrollment

Related Conditions & MeSH terms

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

Intervention

Device:
• Monobloc
Construction fitted to upper and lower jaw
• Bibloc
Biblock construction

Locations

Country	Name	City	State
Sweden	Postgraduate Dental Education Center	Örebro
Sweden	Västmanland County Hospitals	Västerås	Västmanland

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost of care	Total cost calculation including the device, repairs and adjustments and consumption of dentist time	1 year
Primary	Apnoea-Hypopnea-Index (AHI)	AHI defined by American Academy of Sleep Medicine (AASM)	9 weeks after start of study
Secondary	Oxygen Desaturation Index (ODI)	Number of episodes per hour with arterial oxygen saturation decline of 3% or more	9 weeks
Secondary	Sleepiness	Epworth Sleepiness Scale (ESS)	9 weeks and 1 year
Secondary	Quality of life	Functional Outcomes of Sleep Questionnaire (FOSQ )	9 weeks and 1 year
Secondary	Sleep bruxism	Bruxism episodes during sleep	9 weeks
Secondary	Adverse events	Subject reported and objective investigator observed events	1 year