None listed
Conditions
Brief summary
Currently, patients who are suspected of having obstructive sleep apnea (OSA) need to be seen by a sleep specialist and undergo a full sleep study in a laboratory to confirm the diagnosis. A full sleep study involves monitoring of brain waves, eye and chin muscle movements to determine different stages of sleep, breathing patterns, oxygen levels, heart rate and leg movements. Waiting lists to see a specialist and have a laboratory sleep study can often be long, even up to 6-12 months in some centres. To address this problem, increasing numbers of simplified sleep recording devices designed to be used in the patients’ own home are being developed, and have a smaller number of channels recording only breathing patterns and/or oxygen levels overnight, without recording of brain waves to determine stages of sleep. It is currently unclear whether patients who undergo simplified sleep study recordings to test for OSA have treatment results (for example, in the degree of improvement in their symptoms) compared to patients who undergo full sleep studies. In this study, patients referred to a sleep specialist for investigation of possible OSA will be randomly assigned to one of three groups for diagnosis: (1) an overnight sleep study with full monitoring of brain waves, eye and chin muscle movements, breathing patterns, oxygen levels, heart rate and leg movements; (2) an overnight sleep study with monitoring of only breathing patterns, oxygen levels, and heart rate or (3) an overnight sleep study with monitoring of only oxygen levels. The aim of the study is see whether patients who receive treatment from a sleep specialist on the basis of a simplified sleep study recording will do as well (in terms of improvement in symptoms and ability to perform usual daily activities) as patients who have had a full sleep study after 3 months of follow-up.
Interventions
Patients will be randomly assigned to management by their sleep physician following disclosure of sleep study information according to one of three levels of testing:
Level 1 sleep study: Full polysomnography
Level 3 sleep study: Limited sleep study, with airflow, respiratory thoraco-abdominal movement, ECG and oxygen saturation only
Level 4 sleep study: Limited sleep study, with oxygen saturation only
Following randomisation, all patients will undergo full polysomnography (PSG) testing over a
Patients will be randomly assigned to management by their sleep physician following disclosure of sleep study information according to one of three levels of testing: Level 1 sleep study: Full polysomnography Level 3 sleep study: Limited sleep study, with airflow, respiratory thoraco-abdominal movement, ECG and oxygen saturation only Level 4 sleep study: Limited sleep study, with oxygen saturation only Following randomisation, all patients will undergo full polysomnography (PSG) testing over a single night (ie at least 6 hours) in a sleep laboratory. All information will be de-indentified and transferred to a central sleep laboratory (ie Adelaide Institute for Sleep Health), where studies will be scored using data from channels which correspond to the level of sleep study testing that the patient is randomised to, as well as their full PSG. For patients randomised to the Level 3 or 4 arms, the sleep physician will only be given results for the limited sleep study, with disclosure of the full PSG being withheld until after the 4 month follow-up period.
Sponsors
Australasian Sleep Trials Network
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
25 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1) Patients must be aged between 25-80 years. 2) Are referred to a sleep disorders centre for investigation of suspected OSA. 3) Report at least 2 of the following symptoms: snoring, witnessed apneas and/or excessive daytime sleepiness.
Exclusion criteria
1) Have had a previous sleep study 2) Referral for a non-respiratory sleep disorder 3) Have a severe psychiatric disorder or cognitive impairment that may affect the ability of the subject to comply with the study protocol 4) Suffer from neuromuscular disease, severe chronic obstructive (FEV1/FVC <70% and FEV1 <50% predicted) or restrictive (TLC <70% predicted) pulmonary disease, or require supplemental oxygen 6) Have unstable cardiovascular disease or cardiac failure (ie New York Heart Association categories III-IV)
Outcome results
None listed