Targeted Therapy for Sleep Apnoea: A Novel Personalised Approach

Phase 1

Completed

• Conditions: Obstructive sleep apnoea; Respiratory - Sleep apnoea

• Registration Number: ACTRN12618001995268
• Lead Sponsor: euRA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-12
• Study Completion: 2022-09-06
• Last Update Posted: 24 April 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

•Adult men and women with OSA aged between 18 and 80 years who are otherwise healthy.
•Have been recommended MAS by their sleep physician for treatment of their OSA and have had an incomplete therapeutic response (residual AHI>10 events/h sleep)
•Are able to undergo an MRI scan, and do not have any dental implants, crowns or bridges (up to n=40 only for imaging sub-study)
•Participants who are willing and able to give written informed consent and willingness to participate and comply with the study procedures

Exclusion Criteria

•People with contraindications to MRI, which include the presence of a pacemaker, metal shards (e.g. from shrapnel or association with meta work) or other metal implants in the body, in particular dental crowns, implants or bridges (n=40 subset only)
•Contraindications to MAS treatment (periodontal disease or dental caries, less than 10 teeth per dental arch, exaggerated gag reflex)
•Patients taking medications known to affect sleep or pharyngeal muscle activity.
•Patients with previous side effects or known allergy to zolpidem
•People with intellectual or mental impairment or any condition that may interfere with their ability to consent for themselves
•Patients with a previous history of addiction to alcohol or drugs
•Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study
•Patients with any other medical condition which may interfere in the evaluation of the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
OSA severity as measured by the AHI ( number of apnoeas and hypopnoeas per hour of sleep) quantified from overnight polysomnography (Arms 1 and 2).[Overnight sleep study]

Secondary Outcome Measures

Name	Time	Method
Sleep efficiency quantified from overnight polysomnography (Arms 1 and 2).[Overnight sleep study];Oxygen desaturation quantified from overnight polysomnography (Arms 1 and 2).[Overnight sleep study];Arousal Index quantified from overnight polysomnography (Arms 1 and 2).[Overnight sleep study];Upper airway dimensions and genioglossus motion with and without MAS and during oral versus nasal breathing during MRI (Arm 3)[MRI scan visit ]