The Anti-snoring Bed

NCT04053738 | Completed

• 1 other identifier: ASB
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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..

Conditions

Snoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Self-Reported Sleep Quality

  upon awakening - 4 nights

Study Arms (2)

Baseline

NO INTERVENTION

Participants slept in the anti-snoring bed in the laboratory, but the bed did not provide any intervention

Anti-snoring Intervention

EXPERIMENTAL

Participants slept in the anti-snoring bed in the laboratory, and the bed moved the trunk of the participant

Device: Anti-snoring bed

Interventions

Anti-snoring bed DEVICE

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.

Anti-snoring Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• none

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• University of Zurich: collaborator

Study Sites (1)

Sensory-Motor Systems Lab, ETH Zurich

Zurich, 8092, Switzerland

Location

MeSH Terms

Conditions

Snoring

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Riener, Prof. Dr. Dr.-Ing.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were not informed prior to going to bed whether the night would be an intervention night or not
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 12, 2019
• Study Start: January 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: August 12, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)