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Do sleep studies improve outcomes for patients with respiratory failure who need to use long-term non-invasive ventilation?

In individuals with chronic respiratory failure that require non-invasive positive pressure ventilation (NIPPV), does polysomnography titration, compared to clinical titration, improve sleep, physiological and subjective patient-reported outcomes

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613001372774
Acronym
PSG4NIV
Enrollment
60
Registered
2013-12-13
Start date
2013-12-17
Completion date
2015-12-30
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is hoping to determine if overnight monitoring in the form of a sleep study can improve the way we set up non-invasive ventilation (a form of assisted breathing that uses a nose or face mask connected to a ventilator)

Interventions

Clinical titration of NIPPV settings using daytime monitoring techniques (such as pulse oximetry, clinical assessment and daytime arterial blood gases where required). These will be performed by an experienced respiratory physiotherapist under the supervision of a respiratory/sleep physician. Clinical titration will occur during daylight hours (over typically 2-4hrs) on a single occasion. After an acclimatisation period (2 weeks), those in the intervention group will undergo a single night i

Clinical titration of NIPPV settings using daytime monitoring techniques (such as pulse oximetry, clinical assessment and daytime arterial blood gases where required). These will be performed by an experienced respiratory physiotherapist under the supervision of a respiratory/sleep physician. Clinical titration will occur during daylight hours (over typically 2-4hrs) on a single occasion. After an acclimatisation period (2 weeks), those in the intervention group will undergo a single night in-lab attended polysomnography titration of non-invasive positive pressure ventilation (NIPPV). These will be performed and supervised by a sleep scientist and settings will be adjusted to optimise pulse oximetry, reduce hypoventilation and improve synchrony between the patient and the device. Optimised settings will subsequently be determined by a sleep physician experienced in the use of NIPPV and interpretation of polysomnography studies. Participants will continue to use NIPPV every night as prescribed before returning after 6 weeks for a PSG and repeat measures.

Sponsors

Institute for Breathing and Sleep
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Medically stable Suitable for elective (outpatient) implementation of NIPPV Clinical indication to commence long term NIPPV according to local protocols, published guidelines or specialist opinion Confirmed clinical diagnosis of underlying cause of respiratory failure

Exclusion criteria

Hypoventilation attributable to medications with sedative/respiratory depressant effects Previous use of NIPPV for more than 1 month in the previous 3 months Not proficient in English Inability to provide informed consent Previous intolerance of NIPPV Pregnancy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026