NCT05134402

Recording of Multiple Nights Using a New Contactless Device (Sleepiz One Connect) in Obstructive Sleep Apnea

Completed Last updated 10 October 2023

What this trial tests

trial testing Sleepiz One Connect in Obstructive Sleep Apnea in 25 participants. Completed in 31 December 2022.

Timeline

1 December 2021

Primary endpoint
31 December 2022

31 December 2022

Quick facts

Lead sponsor	Samuel Tschopp
Status	Completed
Study type	OBSERVATIONAL
Enrollment	25
Start date	1 December 2021
Primary completion	31 December 2022
Estimated completion	31 December 2022
Sites	1 location across Switzerland

Drugs / interventions tested

• Sleepiz One Connect

Conditions studied

• Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →
• Sleep Apnea — all drugs for Sleep Apnea →
• Respiratory Tract Disease — all drugs for Respiratory Tract Disease →
• Respiration Disorder — all drugs for Respiration Disorder →

Sponsor

Samuel Tschopp

Who can join

18 and older, any sex, with Obstructive Sleep Apnea or Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The need for multiple night testing is well recognized in sleep medicine because of a considerable and relevant night-to-night variability. In a study with multiple recordings using WatchPAT®, the OSA severity of 24% of patients was misclassified when using one night compared to the average of three nights. On average, pAHI varied by 57% from night-to-night. The variability of pAHI could partially be explained by the variability of time spent in the supine position with more time supine leading to a higher pAHI (Tschopp et al 2021). Smith (2007) suggested that the AHI should be indicated with a confidence interval to indicate the uncertainty regarding its true value. The Minimal Detectable Difference (MDD) is of special interest in sleep medicine, especially when assessing treatment effects. MDD was found to be 12.8/h and the standard error of measurement was 4.6/h for 4 nights of polysomnography (Aarab et al. 2008). For WatchPAT®, measuring two and three nights showed a small reduction in MDD from 19.1/h to 18.0/h (Tschopp et al. 2021, in press). Only one study using pulse oximetry assessed the night-to-night variability over 14 days (Stöberl A. et al 2017). The study confirmed the enormous variability and focused mainly on its impact on OSA severity.

While the night-to-night variability has been extensively studied for polysomnography, respiratory polygraphy, and WatchPAT®, little is known about the optimal number of nights to be recorded. There is convincing evidence from the literature, that the recording of multiple nights is the only way to assess the severity of the patient's disease with clinically reasonable accuracy. Moreover, the MDD with only one night's recording is astonishingly high. The question is how many nights should be recorded to achieve acceptable diagnostic accuracy. The precision of the OSA measurement depends on the clinical situation. For example, to diagnose severe OSA, a higher variability might be acceptable without influencing the treatment decision. However, when comparing treatment effects, the MDD should be as small as possible. The recording of multiple nights might be cumbersome for patients (e.g. with polysomnography or respiratory polygraphy) as well as costly. These factors have to be taken into consideration for the clinically feasible number of recordings.

Sleepiz One Connect offers the unique opportunity for a contactless recording of breathing combined with conventional pulse oximetry and is a minimally invasive diagnostic tool that allows measurements over several nights. Studies with multiple night recordings will offer a basis for diagnostic recommendations in future guidelines.

The study aims to investigate the variability of obstructive sleep apnea at-home sleep apnea testing. By investigating the variability, we want to quantify the improvement in diagnostic accuracy by additional measurements.

The hypothesis is that additional recordings offer a significant improvement in diagnostic accuracy by reducing the variability. The reduction in variability will diminish with each additional recording.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Long-term night-to-night variability of sleep-disordered breathing using a radar-based home sleep apnea test: a prospective cohort study.
   Tschopp S, Borner U, Caversaccio M, Tschopp K. · · 2024 · cited 6× · PMID 38415722 · DOI 10.5664/jcsm.11070