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Randomized Controlled Trial
. 2024 Jul;24(4):100231.
doi: 10.1016/j.clinme.2024.100231. Epub 2024 Jul 22.

Mandibular movement monitor provides faster, yet accurate diagnosis for obstructive sleep apnoea: A randomised controlled study

Affiliations
Randomized Controlled Trial

Mandibular movement monitor provides faster, yet accurate diagnosis for obstructive sleep apnoea: A randomised controlled study

Sulaiman S Alsaif et al. Clin Med (Lond). 2024 Jul.

Abstract

Many patients with obstructive sleep apnoea (OSA) remain undiagnosed and thus untreated, and in part this relates to delay in diagnosis. Novel diagnostic strategies may improve access to diagnosis. In a multicentre, randomised study, we evaluated time to treatment decision in patients referred for suspected OSA, comparing a mandibular movement (MM) monitor to respiratory polygraphy, the most commonly used OSA detection method in the UK. Adults with high pre-test probability OSA were recruited from both northern Scotland and London. 40 participants (70 % male, mean±SD age 46.8 ± 12.9 years, BMI 36.9 ± 7.5 kg/m2, ESS 14.9 ± 4.1) wore a MM monitor and respiratory polygraphy simultaneously overnight and were randomised (1:1) to receive their treatment decision based on results from either device. Compared to respiratory polygraphy, MM monitor reduced time to treatment decision by 6 days (median(IQR): 13.5 (7.0-21.5) vs. 19.5 (13.7-35.5) days, P = 0.017) and saved an estimated 29 min of staff time per patient.

Keywords: Diagnostic pathways; Digital health; Mandibular movement; Obstructive sleep apnoea (OSA); Remote diagnosis; Telemedicine.

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Conflict of interest statement

Declaraton of competing interest MJM discloses being a co-applicant on a European Institute of Innovation & Technology grant, developing e-health and integrated care. MIP discloses being a paid consultant for Philips Respironics. JLK discloses speaking fees from Sunrise SA.

Figures

Fig 1
Fig. 1
An illustration of normal breathing during sleep (Left). Partial closure of the upper airway with reduced airflow results in hypopnoea (Middle) and complete closure of the upper airway with no airflow results in apnoea (Right). Originally drawn by Shoroq Alashqar.
Fig 2
Fig. 2
Patient flow diagram for the Sunrise Obstructive Sleep Apnoea Trial (SOSAT). MM: mandibular movement; RP: respiratory polygraphy; MDT: multi-disciplinary team.
Fig 3
Fig. 3
Consolidated Standard of Reporting Trials (CONSORT) flow diagram for the Sunrise Obstructive Sleep Apnoea Trial (SOSAT).
Fig 4
Fig. 4
shows a significant reduction in time to treatment decision (P = 0.017) when using sleep study results from the mandibular movement (MM) monitor (n = 18; median: 13.5; IQR: 7.0–21.5 days), compared to the respiratory polygraphy (RP) monitor (n = 18; median: 19.5; IQR: 13.7–35.5 days).
Fig 5
Fig. 5
Bland-Altman plot of the difference (MM monitor estimated AHI minus RP AHI) vs. average AHI of both devices (n = 30). MM monitor overestimated AHI, compared to respiratory polygraphy; the dashed black line in the middle indicates the mean bias of +4.47 (SD 17.24) events/hour. The 95 % limits of agreement are marked by the above and below dotted lines. Shapes are based on the RP AHI thresholds. MM: mandibular movement; RP: respiratory polygraphy.
Fig 6
Fig. 6
shows the ease of use and comfort of the sleep study devices. Participants (n = 35) made a vertical mark on (10 cm) visual analogue scales. (A) Participants reported that the MM monitor was easier to set up compared to RP monitor (P = 0.0141). (B) Participants found the MM monitor more comfortable to sleep with compared to RP monitor (P = 0.0002). MM: mandibular movement; RP: respiratory polygraphy.
Fig 7
Fig. 7
Participants (n = 35) expressed a preference for at-home sleep study testing over in-hospital sleep tests (A). Participants (n = 35) also indicated their preference for the sleep study device, favouring MM monitor over RP monitor (B). MM: mandibular movement; RP: respiratory polygraphy.

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