None listed
Conditions
Brief summary
The study aims to assess whether a novel type of mandibular advancement device (MAD) design that does not require retention on the teeth is effective in the treatment of obstructive sleep apnoea (OSA). Specifically, the study will compare two settings (active vs sham) of the MAD. Participants that meet the selection criteria undergo a 4 week sham treatment and 4 week active treatment phase with the order being determined randomly. There is a washout period of 1 week after the initial 4 weeks of treatment. The participants will be informed of the nature of each phase at the study conclusion, i.e., the end of 9 weeks period.
Interventions
This is a prospective, randomised sham-controlled crossover trial. Treatment order (active vs sham) will be randomised. Participants are allocated into Groups A and B according to the randomised treatment orders. Total duration of the study is 9 weeks.
-Group A: Active iSlpr® oral device will be worn for a period of 4 weeks followed by the sham oral device for a period of 4 weeks.
-Group B: Sham oral device will be worn first for a period of 4 weeks followed by the active iSlpr® oral device for
This is a prospective, randomised sham-controlled crossover trial. Treatment order (active vs sham) will be randomised. Participants are allocated into Groups A and B according to the randomised treatment orders. Total duration of the study is 9 weeks. -Group A: Active iSlpr® oral device will be worn for a period of 4 weeks followed by the sham oral device for a period of 4 weeks. -Group B: Sham oral device will be worn first for a period of 4 weeks followed by the active iSlpr® oral device for a period of 4 weeks. During the treatment period, the oral device will be worn nightly at the participant’s home, and time recorded in the compliance sleep diary when participant goes to bed and will be removed when they wake up in the morning. There is no minimum or maximum time limit for oral device wearing. There is a one-week washout period between the two 4-week intervention periods during which the participant will not be wearing any oral device when they go to bed. Sleep time will be recorded in the compliance sleep diary during this period. At the start of the study, personalized device fitting for participant will be overseen by a qualified dentist with expertise in mandibular advancement device fitting, during a 30-minute visit. Participants will be educated on the titration of their devices during the dental visit. Participants will be required to titrate to their maximum level of comfort over the duration of their respective 4-week treatment period. They will be instructed to wear either the active iSlpr® oral device or the sham oral device during the first 4-week period according to their randomised treatment order, and the other oral device, respectively, during the second 4-week period. Participants will also be educated on the use of the oral devices and proper cleaning technique by verbal instruction from the dentist only. Both the active iSlpr® customized mandibular advancement device and sham device will be provided to all participants in the study at no cost. All participants will be monitored to ensure their adherence to the interventions for the duration of the study. They are required to keep daily record of their use of the device and sleep time in the compliance sleep diary. Thirty-minute weekly follow-up phone call by the study coordinator will begin once the participant has received their oral devices after the dental device fitting to monitor adherence, to provide support/ answer queries from participants. Participants will be permitted to retain the active iSlpr® oral device free of charge at the conclusion of the trial if deemed clinically useful by the treating sleep physician.
Sponsors
Prof Andrew Chan
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed