Finger and wrist worn peripheral arterial tonometry (WatchPAT) compared to a home-based sleep study for the diagnosis of obstructive sleep apnoea

Peripheral Arterial Tonometry based Home Sleep Apnoea Testing compared to Home Polysomnography for the diagnosis of obstructive sleep apnoea

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12623000164695

Enrollment

450

Registered

2023-02-17

Start date

2023-05-01

Completion date

2024-05-01

Last updated

2023-02-27

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

Conditions

None listed

Brief summary

Laboratory polysomnography (PSG) is costly and labour intensive and therefore cannot adequately deal with the large burden of Obstructive sleep apnoea (OSA) in the community. With technological developments there has been a global trend to home-based sleep testing, both with full PSG at home and limited channel home sleep apnoea testing (HSAT) devices, in order reduce the cost and increase the access to OSA diagnosis. The WatchPAT is a simplified, wrist and finger worn device, which measures peripheral arterial tonometry (PAT), a marker of autonomic tone. WatchPAT and similar devices can measure oxygen saturation and from the PAT signal derive measures of sleep staging and sleep apnoea severity. The WatchPAT is in common clinical use and has been validated against laboratory PSG, but there is limited validation against home based PSG in a general sleep clinic population. This multicentre study aims to assess the diagnostic accuracy of the WatchPAT compared to home based polysomnography in sleep clinic patients referred for the diagnosis of OSA.

Interventions

Study procedures: All participants have standard home full PSG montage using Somte PSG (Compumedics™). WatchPAT 300 is simultaneously worn on the opposite finger and wrist to the oximeter probe from the home PSG. Both Watch-PAT and home PSG will be worn together while the participant is sleeping overnight (minimum 4 hours overnight) Both devices removed upon waking and returned to the Sleep Centre the following morning as per standard practice Home PSG staged and scored using Compumedics Profusion PSG according to American Academy of Sleep Medicine (AASM) criteria (recommended) by the experienced local academic centre by scorers, blinded to WatchPAT results. This will be used by the clinical services for patient care. All PSG raw data also transferred securely to Monash Sleep Centre, Monash Health for blinded analysis for 2nd staging and scoring by a single individual scorer WatchPAT data uploaded to CloudPAT™ data analysis platform and analysed using autoscoring algorithm

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

All consecutive patients age greater than or equal to 18 undergoing home PSG for assessment of snoring or suspected OSA

Exclusion criteria

• Investigation for disorders other than OSA • Inability to consent • Cognitive or physical impairment which would prevent adequate test performance (laboratory PSG performed instead) • < 4 hours sleep time on Home PSG • < 4 hours adequate airflow or oximetry signal on Home PSG

Outcome results