None listed
Conditions
Brief summary
When patients are established on CPAP treatment, they must first undergo a titration study of some description which determines the pressure required to hold the upper airway open. Most patients are assigned a nasal mask in the first instance, and will be swapped to a full-face mask if the nasal mask is not tolerated or does not form an adequate airtight seal. We have noted in our laboratory that standard full-face masks require higher therapeutic pressures than nasal masks, and think this may because a standard full-face mask places pressure on the lower jaw, pushing it back and narrowing the upper airway. We therefore aim to test the hypothesis that masks which seal over the nose only, or full-face masks that seal underneath the chin, require a similar therapeutic pressure which is significantly lower than that required with a standard full-face mask.
Interventions
Patients will be assigned a standard full-face mask and an under-chin full-face mask (two interventions).
Mask interfaces for continuous positive airway pressure (CPAP) for obstructive sleep apnoea (OSA) can cover the patient's nose, mouth or both. A standard full-face mask forms a seal from the bridge of the nose to just underneath the lower lip. An under-chin full-face mask is larger, and forms a seal from the bridge of the nose to underneath the lower jaw.
Each mask will be worn for two c
Patients will be assigned a standard full-face mask and an under-chin full-face mask (two interventions). Mask interfaces for continuous positive airway pressure (CPAP) for obstructive sleep apnoea (OSA) can cover the patient's nose, mouth or both. A standard full-face mask forms a seal from the bridge of the nose to just underneath the lower lip. An under-chin full-face mask is larger, and forms a seal from the bridge of the nose to underneath the lower jaw. Each mask will be worn for two consecutive nights, for as long as the patient is asleep (at least four hours per night). There will be no washout between the three arms.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult (greater than or equal to 25 years) Moderate/severe OSA at baseline (AHI greater than or equal to 30) Compliant with CPAP (using treatment greater than or equal to 4 hours per night on average) Currently using a standard nasal cushion mask without chinstrap Subjectively report predominant supine sleep
Exclusion criteria
Complete upper and/or lower denture Excessive alcohol or caffeine intake Significant cardiac, respiratory or sleep co-morbidity Unwilling to restrict alcohol intake to less than or equal to 2 standard drinks per day for the trial duration.
Outcome results
None listed