The Anti-snoring Bed

• Sponsor: Swiss Federal Institute of Technology (Other)
• Overall Status: Completed
• CT.gov ID: NCT04053738
• Collaborator: University of Zurich (Other)
• Enrollment: 22
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.9
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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..

Condition or Disease	Intervention/Treatment	Phase
Snoring	Device: Anti-snoring bed	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Masking Description: Participants were not informed prior to going to bed whether the night would be an intervention night or not
• Primary Purpose: Treatment
• Official Title: An Intelligent Bed To Monitor And Reduce Snoring
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Jul 1, 2018
• Actual Study Completion Date: Jul 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Effect on snoring [whole night - 4 nights]

   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.

Secondary Outcome Measures

1. Self-Reported Sleep Quality [upon awakening - 4 nights]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sensory-Motor Systems Lab, ETH Zurich	Zurich		Switzerland	8092

Sponsors and Collaborators

• Swiss Federal Institute of Technology
• University of Zurich

Investigators

• Principal Investigator: Robert Riener, Prof. Dr. Dr.-Ing., University of Zurich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Swiss Federal Institute of Technology
• ClinicalTrials.gov Identifier: NCT04053738
• Other Study ID Numbers: ASB
• First Posted: Aug 12, 2019
• Last Update Posted: Aug 12, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Snoring

Study Results

No Results Posted as of Aug 12, 2019