None listed
Conditions
Interventions
Night 1: Sleep study titration review study on non-invasive ventilation (with titration of inspiratory time during the study and no chinstrap).
Nights 2,3 & 4 at home acclimatizing to NIV without chinstrap. (inspiratory duration not set)
Night 5, 6 & 7: Three experimental nights in randomized order
Inspiratory duration set no chinstrap
Inspiratory duration not set no chinstrap
Inspiratory duration set with chinstrap
The duration on the experimental interventions is one night each.
Sponsors
ResMed Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with documented nocturnal hypoventilation from any cause. Using non-invasive ventilation chronically at home. Be using a bilevel pressure preset ventilator at home in the spontaneous mode. Be using a nasal interface with NIV. Preferably to be using NIV without the use of supplemental oxygen. To be included in the study, subjects will: 1. Have to have sustained improvements in gas exchange and symptomatolgy. 2. Be compliant with non-invasive ventilation at home (using >5hrs per night). 3. Able to attend the sleep laboratory on 3 nights within the trial period (ie 6 nights).
Exclusion criteria
Subjects will be excluded from the study where: 1. Their is limited upper limb movement which would prevent or limit the removal of the nasal mask. 2. Significant psychiatric or psychological conditions exist which are likely to prevent accurate reporting in regard to the comfort of therapy. 3. A history of acute respiratory illness within the last month. 4. The taking of any hypnotic or anti-depressant medication.
Outcome results
None listed