The Anti-snoring Bed

Snoring Clinical Trial

Official title:

An Intelligent Bed To Monitor And Reduce Snoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04053738
• Other study ID #: ASB
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: July 1, 2018

Study information

• Verified date: August 2019
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Snoring

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Sensory-Motor Systems Lab, ETH Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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