None listed
Conditions
Brief summary
Latest research demonstrates that up to 40 million Americans (17%), and 4 million Australians (17%) suffer from snoring and/or Obstructive Sleep Apnoea (Kryger, Roth, Rement Principles and Pracice of Sleep Medicine, 5th Ed.). Nevertheless, only a small percentage have received treatment (5% in America and less than 1% in Australia; American Society of Sleep Medicine, USA, 2014). Current treatments are costly, time-consuming and difficult to tolerate. The Power Sleep (PS) oral device is a non-customised, self-fitted intra-oral mandibular advancement splint designed to manage snoring and sleep apnoea. This product has the potential to deliver a clinically effective outcome while reducing cost and increasing comfort levels. The current study aims to examine the efficacy and safety of the Power Sleep (PS) oral device in the management of snoring and sleep apnoea. A pre-post test design involving measures at baseline and using the oral device will be employed using approximately 30 participants aged 18-65 with sleep apnoea. It is hypothesized that the Power Sleep (PS) oral device will have a salutatory effect compared to baseline measures on: (a) snoring loudness; (b) snoring frequency; (c) Apnoea Hypopnea Index-REM (AHI-REM); (d) Apnoea Hypopnea Index-Total (AHI-Total); and (e) mean minimum oxygen saturation (min SaO2).
Interventions
The Power Sleep device is a non-customised, self-fitted intra-oral mandibular advancement splint designed to manage snoring and mild sleep apnoea. The Power Sleep device will be used for a single night whilst in bed, while simultaneously linked to an overnight polysomnography sleep study device at the participant's own home. Adherence will be measured using a single-item question "On the night that you used the device, for how much of the night did you use the device?" with responses ranging on
The Power Sleep device is a non-customised, self-fitted intra-oral mandibular advancement splint designed to manage snoring and mild sleep apnoea. The Power Sleep device will be used for a single night whilst in bed, while simultaneously linked to an overnight polysomnography sleep study device at the participant's own home. Adherence will be measured using a single-item question "On the night that you used the device, for how much of the night did you use the device?" with responses ranging on a four point likert scale consisting of o (did not use device), 1 (some of the night), 2 (most of the night), 3 (the entire night).
Sponsors
Associate Professor Jack Gerschman
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Apnea Hypopnea Index-Total (AHI-total) score of five (5) or greater (assessed by overnight PSG home sleep study). This includes participants ranging from mild to severe in severity of sleep apnoea.
Exclusion criteria
Unstable cardiovascular disease (untreated hypertension acceptable); Upper or lower respiratory tract disease (e.g., upper respiratory tract infection, rhinitis, sinusitis, chronic obstructive pulmonary disease), including a history of nasal allergy; Dental pathology such as infection, abscess in bone, tumour, cracked teeth, and severe dental decay; Inability to tolerate oral device due to oral or psychological condition; Pregnant/Breast Feeding; Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as co-existent other sleep disorder, psychiatric disease, history of non-compliance to medical regimens, or unwillingness to comply with study requirements; Known widespread allergy or hypersensitivity (Atopia).
Outcome results
None listed