Efficacy and tolerability of a novel adjustable mandibular advancement device (iSlpr®) for Obstructive Sleep Apnoea: A pilot study

Not Applicable

Conditions: Obstructive Sleep Apnoea (OSA)
Respiratory - Sleep apnoea

Registration Number: ACTRN12621000308897

Lead Sponsor: Prof Andrew Chan

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Stopped early

Sex: All

Target Recruitment: 5

Inclusion Criteria

1. New diagnosis of at least moderate OSA with an AHI of equal to or greater than 15 events per hour
2. Aged 18 years and older
3. At least two symptoms of OSA from the following:
-Snoring
-Fragmented sleep
-Witnessed apnoeas
-Daytime sleepiness
4. Willingness to provide informed consent and to participate in a 9 week trial of two novel oral appliances.
5. Proficiency in English

Exclusion Criteria

1. Very severe OSA classified as an AHI of equal to or greater than 50 events per hour and/or a minimum oxygen desaturation of equal to or less than 70%.
2. Need for immediate treatment of OSA based on clinical judgement of sleep physician, including unstable comorbidities or driving risk (e.g. commercial drivers)
3. Co-existing sleep disorders or Central Sleep Apnoea
4. Regular use of sedatives or narcotics
5. Any contraindication for oral appliance therapy including poor oral hygiene, mobile teeth, temporomandibular dysfunction, other oral conditions as deemed by the dentist
6. Unstable psychiatric or psychological illness that would prevent accurate reporting
7. Pregnancy
8. Participant is unable to understand the research project.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of active iSlpr® oral device as measured by the change in apnoea hypopnoea Index (AHI), as per current American Academy of Sleep Medicine (AASM) guidelines, determined by a diagnostic sleep study using polysomnography device.[ Baseline, the end of 4 and 9 weeks (primary timepoint) post-treatment commencement]

Secondary Outcome Measures

Name	Time	Method
Participant acceptance assessed by the proportion of participants who continue to wear the device calculated using the study database.[ Weekly post-treatment commencement for 9 weeks];Participant tolerability assessed by a questionnaire designed specifically for this study[ Weekly post-treatment commencement for 9 weeks];Composite outcome: Sleep quality assessed by the standard Berlin Questionnaire and Epworth Sleepiness Scale Questionnaire, and study-specific Snoring Visual Analogue Scale and Questionnaire [ Weekly post-treatment commencement for 9 weeks];Participant feedback on feasibility of device use assessed by a questionnaire designed specifically for this study[ At the end of 9 weeks post-treatment commencement];Self-assessment perceived side effects assessed by a questionnaire designed specifically for this study[ At the end of 9 weeks post-treatment commencement, 6 months post-study completion]