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A prospective validation of a simplified Screening model of questionnaire and oximetry for detecting moderate to severe Obstructive Sleep Apnoea in chronic Tetraplegia. (SOSAT)

A prospective validation of a simplified Screening model of questionnaire and oximetry for detecting moderate to severe Obstructive Sleep Apnoea in chronic Tetraplegia. (SOSAT)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000896572
Acronym
SOSAT
Enrollment
105
Registered
2015-08-27
Start date
2015-09-10
Completion date
2017-06-27
Last updated
2026-06-01

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

Conditions

None listed

Brief summary

Approximately 50% of people with tetraplegia have obstructive sleep apnoea (OSA), which is a direct consequence of their injury. OSA has been linked to poor quality of life and problems with memory, learning and concentration in people with tetraplegia. Current guidelines recommend that all people with tetraplegia and symptoms of sleepiness undergo a full sleep study (polysomnography) to diagnose OSA or not. However, very few spinal units have access to this expensive and highly specialised equipment, a sleep scientist to perform the test and a sleep physician to understand and communicate the results. It is therefore likely that most people with tetraplegia and OSA are undiagnosed and untreated. This project aims to test whether a questionnaire followed by overnight oximetry (a finger probe that measures the oxygen level of the blood) can accurately detect moderate to severe OSA in people with tetraplegia. If successful, this simple screening test could replace the need for a full sleep study. Improving the diagnosis of this condition will enable many people with tetraplegia and OSA to access treatment for their condition with likely improvement in their quality of life.

Interventions

Diagnosis of obstructive sleep apnoea - the diagnostic test under evaluation is a two stage screening model of questionnaire and overnight oximetry. The OSA50 questionnaire is administered in the evening, followed by one overnight oximetry test, involving non-invasive sensor placed on the finger for the duration of the participant's sleep. The testing is performed in the participant's home or on the inpatient ward (if a current inpatient of the spinal unit).

Sponsors

Institute for Breathing and Sleep
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

- Chronic (at least 1 year since initial injury), traumatic tetraplegia (T1 lesion or higher). - ASIA Impairment Scale A, B, C or D. - Aged 18 and older

Exclusion criteria

- Currently being treated for OSA - Current inpatient admission for a cardiorespiratory related complication - Inability to give informed consent - Medical instability

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 5, 2026