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A comparison of efficacy and tolerability using two portable sleep apnoea monitoring devices: nocturnal oximetry versus nasal airflow in the triage diagnosis and screening of obstructive sleep apnoea.

A comparison of efficacy and tolerability using two portable sleep apnoea monitoring devices: nocturnal oximetry versus nasal airflow in the triage diagnosis and screening of obstructive sleep apnoea.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12605000120673
Enrollment
193
Registered
2005-08-10
Start date
2006-07-03
Completion date
2007-11-01
Last updated
2022-08-09

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

Conditions

None listed

Brief summary

Obstructive Sleep Apnea (OSA) is a common disorder. It is linked to heart disease, stroke high blood pressure and poor cognition as well as motor vehicle and work accidents. However till now the diagnostic gold standard is in hospital overnight sleep study. This is expensive time consuming and has limited availability. Studies investigating the use of simple single channel monitors for OSA detection at home have predominantly involved device that measure oxygen in the blood (oximeters) with limited data available for devices that measure breathing (nasal flow). Our aim was to assess and compare the validity of nasal flow and oximetry recordings using separate single channel monitors in the laboratory on the same night as the sleep study and at home for a single and three nights each with respect to the laboratory sleep study.

Interventions

All subjects will be asked to complete screening questionnaires (the Epworth Sleepiness Scale, The Berlin Questionnaire, the Multivariate Apnea Index and a comfort and ease of use questionnaire) and these will take 3 minutes to complete. Anthropometric and demographic data will also be collected. Participants will be assigned to one of two groups. Group 1 will have their nasal flow measured with a nasal flow pressure transducer and their oxygen concentration measured with an oximeter for one nig

All subjects will be asked to complete screening questionnaires (the Epworth Sleepiness Scale, The Berlin Questionnaire, the Multivariate Apnea Index and a comfort and ease of use questionnaire) and these will take 3 minutes to complete. Anthropometric and demographic data will also be collected. Participants will be assigned to one of two groups. Group 1 will have their nasal flow measured with a nasal flow pressure transducer and their oxygen concentration measured with an oximeter for one night in parallel with in-laboratory full polysomnography (PSG) which involves monitoring sleep, ventilation and muscle activity. Group 2 subjects will have within an 8 week period (according to the patient circumstances and laboratory availability) one night of in-laboratory polysomnography (PSG) and 2 consecutive sets of three nights each at home using oximetry alone and nasal flow monitoring alone in random order without a resting period between each set. They will also be asked to complete the Karolinska Sleep diary for each night at home while using each device. This will take 2 minutes to complete.

Sponsors

Woolcock Institute of Medical Research
Lead SponsorOther

Eligibility

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

Inclusion criteria

1.Subjects presenting to the sleep laboratory for assessment of obstructive sleep apnea 2.Age = 21 3.Able to give consent

Exclusion criteria

1.Clinically significant co morbidity, including any unstable cardiovascular, gastrointestinal, metabolic, pulmonary (e.g., asthma, chronic obstructive pulmonary disease, etc), renal, neurological, hepatic, hematologic, immunologic, endocrine, psychiatric illness and/or neoplastic disease. 2.Patients unable to apply the monitoring devices (e.g. severe hand arthritis, neuromuscular disease). 3.Shift workers 4.Known underlying sleep disorder

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026