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Multicenter Study
. 2022 Dec 1;18(12):2703-2712.
doi: 10.5664/jcsm.10194.

A single-arm, open-label, multicenter, and comparative study of the ANNE sleep system vs polysomnography to diagnose obstructive sleep apnea

Charles Davies  1 , Jong Yoon Lee  2   3 , Jessica Walter  4 , Donghyun Kim  2 , Lian Yu  2 , Junbin Park  2 , Stefanida Blake  5 , Lakshmi Kalluri  5 , Mark Cziraky  6 , Eric Stanek  6 , Julie Miller  6 , Brian J Harty  6 , Jacob Schauer  7 , Stephanie M Rangel  8 , Alexa Serao  8 , Claire Edel  8 , Davina S Ran  8 , Matthew O Olagbenro  8 , Andrew Lim  9 , Kuljeet Gill  10   11 , Jessica Cooksey  11   12 , Omid Toloui  5 , Thomas Power  13 , Shuai Xu  3   8   14   15 , Phyllis Zee  11
Affiliations
Multicenter Study

A single-arm, open-label, multicenter, and comparative study of the ANNE sleep system vs polysomnography to diagnose obstructive sleep apnea

Charles Davies et al. J Clin Sleep Med. .

Abstract

Study objectives: Evaluate per-patient diagnostic performance of a wireless dual-sensor system (ANNE sleep) compared with reference standard polysomnography (PSG) for the diagnosis of moderate and severe obstructive sleep apnea (OSA) with a minimum prespecified threshold of 80% for both sensitivity and specificity.

Methods: A multicenter clinical trial was conducted to evaluate ANNE sleep vs PSG to diagnose moderate and severe OSA in individuals 22 years or older. For each testing approach, apnea-hypopnea index (AHI) was manually scored and averaged by 3 registered sleep technologists blinded to the other system. Average variations > 15% were adjudicated by a sleep medicine physician.

Results: In a total of n = 225 participants (mean age 53 years, range 22-88 years), PSG diagnosed 30% (n = 68) of participants with moderate or severe OSA (AHI ≥ 15 events/h) compared to 29% (n = 65) diagnosed by ANNE sleep (P = .55). The sensitivity and specificity for ANNE sleep were 90% (95% confidence interval: 80-96%) and 98% (95% confidence interval: 94-99%), respectively. Strong correlation was shown in terms of final AHI (r = .93), with an average AHI bias of 0.5 (95% limits of agreement: -12.8 to 11.8). The majority of users noted comfort with using the ANNE sleep in the home setting. No adverse events were noted.

Conclusions: Using PSG as the gold standard, ANNE sleep demonstrated high sensitivity and specificity for the diagnosis of moderate or severe OSA.

Clinical trial registration: Registry: ClinicalTrials.gov; Name: Comparative Study of the ANNE™ One System to Diagnose Obstructive Sleep Apnea; URL: https://clinicaltrials.gov/ct2/show/NCT04643782; Identifier: NCT04643782.

Citation: Davies C, Lee JY, Walter J et al. A single-arm, open-label, multicenter, and comparative study of the ANNE sleep system vs polysomnography to diagnose obstructive sleep apnea. J Clin Sleep Med. 2022;18(12):2703-2712.

Keywords: diagnostic testing; flexible electronics; home sleep apnea testing; obstructive sleep apnea; patient preferences; polysomnography; wireless sensors.

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Conflict of interest statement

All authors have seen and approved the manuscript. Work for this study was performed at Northwestern Memorial Hospital, Carle Foundation Hospital, Central DuPage Hospital, and Lake Forest Hospital. This study was funded by Elevance Health (S.B., L.K.). J.Y.L., H.C., and S.X. also recognize support from the National Institute of Health’s National Heart, Lung, and Blood Institute (1R43HL151549-01). J.Y.L., D.K., J.P., H.C., and D.S.R. are all employees of Sibel Health, the developer of the ANNE One system. The spouse of J.R.W. has stock ownership in Sibel Health and royalties as an inventor. J.Y.L., D.K., J.P., and S.X. report stock ownership in Sibel Health, and royalties as inventors related to the patents associated with the technology. The other authors report no conflicts of interest.

Figures

Figure 1
Figure 1. Experimental system.
The components applied to the body for the experimental system (ANNE sleep) are shown (A). They consist of 2 soft, flexible, wireless sensors that couple to the suprasternal notch and the index finger. The onboard sensors include 1-lead ECG, 3-axis high-frequency accelerometry, thermography, and transmissive mode photoplethysmography. Collectively, these onboard sensors generate measurements for heart rate, respiratory rate, chest wall movement, continuous heart sounds, snoring, body position, SpO2, skin temperature at both a central and peripheral location, and peripheral arterial tonometry. The sensors are software-linked, enabling time synchronization to derive pulse arrival time and pulse transit time. The sensors are mounted (B) on the suprasternal notch and finger with single-use consumables. ECG = electrocardiography, SpO2 = arterial oxygen saturation.
Figure 2
Figure 2. Outputs of the experimental system.
The outputs of the ANNE sleep system are shown derived from a suite of onboard sensors. (A) The outputs derived from the ANNE limb sensor for PAT and SpO2 and ANNE chest sensor for heart rate, snoring, and chest wall movement. During apneic events, there is clear illustration of PAT attenuation, heart rate increases, SpO2 drops, snoring changes, and chest wall movement changes. (B) The system accurately determines body position changes based on the ANNE chest sensor. bpm = beats per minute, HR = heart rate, PAT = peripheral arterial tonometry, SpO2 = arterial oxygen saturation.
Figure 3
Figure 3. PTT derived from experimental system.
(A–D) PTT represents a time interval that corresponds to a pulse wave traveling from the aortic valve to the finger, which can be used to distinguish central and obstructive sleep apnea events. In the case of obstructive events, PTT varies with a sloped appearance given the movement of the chest. In the case of central events, PTT remains relatively flat given the lack of movement of the chest. PTT = pulse transit time.
Figure 4
Figure 4. AHI scored by experimental system compared with PSG.
(A) A 2 × 2 matrix for the diagnosis of moderate to severe OSA for ANNE sleep and PSG. (B) Bland-Altman plot for AHI between ANNE sleep and PSG. (C) The scatterplot illustrates high linear agreement between AHI derived from ANNE sleep compared with AHI derived from PSG. AHI = apnea-hypopnea index, OSA = obstructive sleep apnea, PSG = polysomnography, Sens = sensitivity, Spec = specificity.
See this image and copyright information in PMC

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