Sleep Positional Trainer for Positional Sleep Apnea After Mandibular Advancement Device (MAD) Therapy

Positional Sleep Apnea Clinical Trial

— SupPos  

Official title:

Evaluation of Sleep Position Trainer for Positional Sleep Apnea Patients After Therapy With Mandibular Advancement Device (MAD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01535521
• Other study ID #: SupPos
• Status: Completed
• Phase: N/A
• First received: February 14, 2012
• Last updated: June 19, 2013

Study information

• Verified date: June 2013
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The investigators will perform a clinical trial comparing mandibular advancement device (MAD) therapy with sleep positional trainer (SPT) and the combination of MAD and SPT in patients with positional sleep apnea using MAD. Patients are invited for 2 consecutive polysomnographies (PSGs) in randomized order: one PSG with SPT, one PSG with SPT and MAD. PSGs are performed at the Antwerp University Hospital.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with supine dependent Obstructive Sleep Apnea (OSA) after Mandibular Advancement Device (MAD) Therapy: Apnea Hypopnea Index (AHI) supine = 2x AHI non supine

• 5 < AHI < 50/h sleep on polysomnography (PSG) with MAD in situ

• = 20% supine position during PSG with the MAD in situ

• AHI non-supine < 10/h en AHI supine = 10/h on PSG with MAD in situ

• Unchanged Body Mass Index (BMI)(BMI ± 1 kg/m²) at moment of inclusion compared to BMI at baseline PSG

Exclusion Criteria:

• age < 18 years

Study Design

N/A

Related Conditions & MeSH terms

• Apnea
• Mandibular Advancement Device
• Positional Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Device:
• Sleep Position Trainer (SPT)

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Ethisch Comité UZ Antwerpen

Country where clinical trial is conducted

Belgium,