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    Home-testing devices for diagnosing obstructive sleep apnoea hypopnoea syndrome

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    2 The diagnostic tests

    Clinical need and practice

    Obstructive sleep apnoea hypopnea syndrome

    2.1

    Obstructive sleep apnoea hypopnoea syndrome (OSAHS) is a syndrome in which the upper airway becomes blocked repeatedly during sleep. It can intermittently reduce airflow (hypopnoea) or stop airflow completely (apnoea). Both apnoeas and hypopnoeas can occur in the same night. Symptoms of sleep apnoea include loud snoring, witnessed breathing pauses, gasping, choking, sleep disruption and unrefreshing sleep. Because of the sleep disturbance, symptoms may also occur during waking hours, including excessive sleepiness. Sleep disruption and excessive sleepiness can reduce quality of life, cognitive function and affect mental health. COPD–OSAHS overlap syndrome occurs in people who have both chronic obstructive pulmonary disease (COPD) and OSAHS.

    2.2

    In adults, OSAHS is associated with various adulthood conditions, such as overweight or obesity, hypertension, type 2 diabetes and cardiovascular disease. In children, the most common cause of OSAHS is adenotonsillar hypertrophy (enlarged tonsils or adenoids), which can partially obstruct the airway during sleep.

    Care pathway and clinical need

    2.3

    Recommendations on detecting OSAHS and the care pathway can be found in NICE's guideline on obstructive sleep apnoea/hypopnoea syndrome and obesity hypoventilation syndrome in over 16s and the British Thoracic Society's guideline for diagnosing and monitoring paediatric sleep-disordered breathing. NICE recommends home respiratory polygraphy (RP) as the initial test for OSAHS in people over 16. If home RP is unavailable, home oximetry can be used but oximetry alone may be inaccurate for differentiating between OSAHS and other causes of hypoxaemia in people with heart failure or chronic lung conditions. Hospital RP or polysomnography can also be used if additional monitoring is needed.

    2.4

    Home RP systems include wired components that people need instruction to operate and can be uncomfortable to wear. Oximetry is a widely used alternative.

    2.5

    Expert clinical advice suggests that hospital sleep-testing capacity has reduced since the COVID‑19 pandemic, creating more reliance on home testing for sleep diagnostics. Some devices can be sent directly to the person by the manufacturer or NHS provider, which may increase access to home testing and reduce waiting times. This can potentially reduce time to diagnosis, leading to more timely treatment and symptom improvement. Newer home-testing devices may be easier to put on and operate than the devices currently used in the NHS and may also be more comfortable to wear.

    The interventions

    2.6

    Home-testing devices can be used for diagnosing OSAHS. The devices vary in terms of their indications, contraindications for use, physiological parameters measured, lifespan and their need for an internet connection or a smartphone. Table 1 highlights the device specifications including attachment details, mechanism of detection, and whether they need an internet connection or smartphone. See section 1.3 of the external assessment report for further details on the devices.

    Table 1 Device specifications

    Device name and cost

    Attachment details

    Mechanism of detection

    Internet or smartphone needed

    AcuPebble SA100

    (£40 to £60 per test depending on volume of sleep studies).

    Wireless sensor (throat).

    Records sound generated from physiological body processes including respiratory and cardiac functions.

    Adding a third-party oximeter is optional.

    Internet: to create study in the system (healthcare professional) and to upload the data (this can be done when the device is received by a healthcare professional).

    Smart device (phone or tablet): yes, manufacturer provides it to carry out the test at no additional cost.

    Brizzy

    (£44 per clinical question, reusable device).

    Device hub (waist belt).

    Wired sensors (chin and forehead).

    Measures jaw activity signal including mandibular movement. Adding a third-party oximeter is optional.

    Internet: no.

    Smartphone: no.

    NightOwl

    (£90 per single-use device).

    Wireless sensor (finger).

    Consists of a photoplethysmography sensor and accelerometer that measure peripheral arterial tone (PAT) signal, oxygen saturation, body movement and pulse rate.

    Internet: yes.

    Smartphone: yes.

    Sunrise

    (£75 per single-use device, or £62 for orders over 100 devices).

    Wireless sensor (chin).

    Measures mandibular movement.

    Internet: yes.

    Smartphone: yes.

    WatchPAT 300

    (£50 per resuable device).

    Device hub (wrist strap).

    Wired sensor (finger and chest).

    Measures a proprietary PAT signal, heart rate, oximetry, body movement and position, snoring and chest motion.

    Internet: no.

    Smartphone: no.

    WatchPAT ONE

    (£80 per single-use device).

    Device hub (wrist strap).

    Wired sensor (finger and chest).

    Measures a proprietary PAT signal, heart rate, oximetry, body movement and position, snoring and chest motion.

    Internet: yes.

    Smartphone: yes.

    The comparators

    2.7

    The comparators for people 16 years and over are home RP or home oximetry. For people with COPD or suspected COPD–OSAHS overlap syndrome, oximetry alone is not recommended.

    2.8

    For people under 16 years, the comparators are home RP or home pulse oximetry. Carbon dioxide monitoring may be used alongside these devices.