Improving sleep and quality of life in patients with idiopathic interstitial pneumonia, using nocturnal supplemental oxygen

In patients with idiopathic interstitial pneumonia, nocturnal supplemental oxygen compared with placebo, improves sleep and quality of life

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001286932

Enrollment

Registered

2011-12-15

Start date

2012-07-27

Completion date

2015-07-29

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 aimed at looking at the physiology of sleep in patients with lung fibrosis. Investigators are particularly interested in those people whose oxygen levels fall during sleep, and the role of giving supplemental oxygen in such cases. The hypothesis is that supplemental oxygen during sleep improves a number of health domains, including quality of life, sleep quality, blood flow in the lungs and strain on the heart. Subjects will receive oxygen (or air) during sleep via nasal prongs for 4 weeks. They will then undergo an overnight sleep study. After a two-week "washout" period, they will then receive air (or oxygen) through nasal prongs for 4 weeks, followed by another sleep study.

Interventions

Oxygen (2 litres/min) via nasal cannulae from a concentrator during sleep (approximately 6 to 8 hours per 24 hours), every night for 4 weeks, with an overnight sleep study on day 28. Subjects then have a two week washout period and crossover to receive the sham intervention, as below, for a further 4 weeks, and then another sleep study on day 70. Note: the order of these two arms will be random so as to ensure blinding for subjects and investigators.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

Patients 18 - 80 yrs. Patients able to perform a polysomnogram (sleep study), as determined following clinical assessment. Patients with nocturnal hypoxaemia, defined as >10% of the night with SpO2 <90% on overnight oximetry or PSG Patients able to give informed consent. Patients with idiopathic interstitial pneumonia (IIP), according to American Thoracic Society /European Respiratory Society criteria. Absence of daytime resting hypoxaemia (ie with PaO2 > 55mmHg).

Exclusion criteria

Patients <18yrs or >80yrs. Patients not able to give informed consent. Patients considered unable to complete a PSG by their physician. Presence of daytime resting hypoxaemia (PaO2 less than or equal to 55mmHg). Presence of hypercapnia (PaCO2 > 45mmHg) at baseline Patients who do not meet oxygen saturation criteria for nocturnal hypoxaemia Patients with co-existent obstructive sleep apnoea with apnoea hypopnoea index greater than or equal to 15 with clinical symptoms, or apnoea hypopnoea index greater than or equal to 30 (without symptoms) Patients who are current smokers

Outcome results