RecruitingACTRN12605000415606

The effect of inspiratory duration and chinstrap during non-invasive ventilation

The effect of inspiratory duration and chinstrap during non-invasive ventilation: Effects on sleep quality and gas exchange in subjects with nocturnal hypoventilation

Sponsor

ResMed Ltd

Enrollment

25 participants

Start Date

Oct 30, 2005

Study Type

Interventional

Conditions

Nocturnal hypoventilation

Eligibility

Sex: Both males and females

Inclusion Criteria1

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 Criteria1

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.

Interested in this trial?

Get notified about updates and connect with the research team.

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 c

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.

Locations(1)

Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12605000415606