The Anti-snoring Bed

An Intelligent Bed To Monitor And Reduce Snoring

Habitual snoring is a widespread complication. Most snorers snore predominately when sleeping in supine position. Therefore, therapeutic interventions force snorers to avoid supine position. Devices that restrict the sleeping position or raise alarms when the user obtains the supine position cause discomfort or disrupt sleep resulting in low compliance. Therefore, anti-snoring mechanisms, which lift the trunk of the user without disturbing sleep, have been proposed.

We set out to investigate whether individual interventions provided by beds with lifting mechanisms are able to stop snoring within three minutes (success rate) and whether the bed reduces the snoring index (number of total snores divided by total time in bed). In addition, we investigat whether the trunk elevation provided by the bed is interfering with the subjective sleep quality assessed using the Groningen Sleep Quality Score.

Subjects are observed for four nights (adaptation, baseline, and two intervention nights). During intervention nights, the bed lifts the trunk of the user in closed-loop manner. Subjects are divided in three groups (non-snorers, snorer group one, and snorer group two). Non-snorers are lifted by the bed at random time points during the night. In snorer group one, a stepwise increase of the bed inclination is compared with going directly to a randomly selected angle. In snorer group two, the influence of a small inclination angle (10°) and a big inclination angle (20°) is compared..

Study Overview

• Status: Completed
• Conditions: Snoring
• Intervention / Treatment: Device: Anti-snoring bed

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8092
    • Sensory-Motor Systems Lab, ETH Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• none

Exclusion Criteria:

• Pregnancy
• Previously diagnosed sleep-related breathing disorders
• Chronic lower back pain
• Heart insufficiency that might impede sleeping in supine position
• Inability to follow the procedures of the study, e.g. due to language problems

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Baseline; Participants slept in the anti-snoring bed in the laboratory, but the bed did not provide any intervention
EXPERIMENTAL: Anti-snoring Intervention; Participants slept in the anti-snoring bed in the laboratory, and the bed moved the trunk of the participant	Device: Anti-snoring bed; The mattress shape is adjusted using a custom made intelligent anti-snoring bed, which is able to detect snoring sound and change the position of the user whenever snoring occurs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on snoring	Number of episodes of snoring that are terminated by intervention. Snoring activity was monitored using a portable home-monitoring device (Apnea Link plus, purchased from ResMed, Switzerland). This device records oxygen saturation, nasal airflow, and breathing effort. The device comes with a software package that automatically scores the data according to the sleep scoring rules of the American Academy of Sleep Medicine (AASM). Since audio based detection has been reported to be the most reliable way of snoring detection , we also used a sound level meter (XL2 Audio and acoustic Analyzer, purchased from NTi Audio, Lichtenstein) for manual visual-audio scoring of snoring sound. The sound level meter was placed approximately in the position where you would usually expect the head of the bed partner. Manual visual-audio scoring of the data collected with the noise level meter was performed using the XL2 data explorer.	whole night - 4 nights

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Reported Sleep Quality	Subjective Sleep Quality was assessed using the standardized Groningen Sleep Quality Scale (GSQS). This questionnaire consists of 15 questions, which are to be answered with yes or no. The maximum possible score of 14 indicates a poor sleep the preceding night. Within the study, we used the original English version of the questionnaire.	upon awakening - 4 nights

Collaborators and Investigators

• Sponsor: Swiss Federal Institute of Technology
• Collaborators: University of Zurich
• Investigators: Principal Investigator: Robert Riener, Prof. Dr. Dr.-Ing., University of Zurich

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): July 1, 2018
• Study Completion (ACTUAL): July 1, 2018

Study Registration Dates

• First Submitted: August 7, 2019
• First Submitted That Met QC Criteria: August 9, 2019
• First Posted (ACTUAL): August 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 12, 2019
• Last Update Submitted That Met QC Criteria: August 9, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Respiratory Sounds; Snoring
• Other Study ID Numbers: ASB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No