None listed
Conditions
Brief summary
People with newly diagnosed obstructive sleep apnoea for treatment with continuous positive airway pressure through a nasal mask (cPAP) are assigned to use a new custom fitted mask or the best-fit commercially available standard mask. There are 6 planned study visits over the 12 month treatment period. Participants are asked to complete study questionnaires at each study visit.
Interventions
CPAP treatment of sleep apnoea using a custom fitted mask (the TrueFIT Custom Mask). An impression is taken of the central features of the study participants face. The mask is made, the participant fitted with the mask and educated as to the use of the mask and the ResMed sleep apnea system. The ResMed is a 1.4 kg unit, 112 mm x 164 mm x 145 mm, operating from mains power. The system pumps air at a predetermined increased pressure to the mask and gathers information about mask usage. The pa
CPAP treatment of sleep apnoea using a custom fitted mask (the TrueFIT Custom Mask). An impression is taken of the central features of the study participants face. The mask is made, the participant fitted with the mask and educated as to the use of the mask and the ResMed sleep apnea system. The ResMed is a 1.4 kg unit, 112 mm x 164 mm x 145 mm, operating from mains power. The system pumps air at a predetermined increased pressure to the mask and gathers information about mask usage. The participant is asked to use the mask and Resmed each night for a total of 1 year. The participant's technique with the mask and equipment is reviewed at each study visit, and further education provided as necessary.
Sponsors
Acurest
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age 18 years or older Diagnostic polysomnography at The Wesley Sleep Disorders Centre (TWSDC) with newly diagnosed moderate to severe obstructive sleep apnoea Titration study at TWHDC and assessed as suitable for nasal CPAP therapy Willing to comply with all study requirements Able to understand and follow verbal and written instruction Able to give written consent
Exclusion criteria
Medical or psychological conditions which according to the investigator interfere with trial participation. Previous CPAP treatment
Outcome results
None listed