The Anti-snoring Bed
Primary Purpose
Snoring
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Anti-snoring bed
Sponsored by
About this trial
This is an interventional treatment trial for Snoring
Eligibility Criteria
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
Sites / Locations
- Sensory-Motor Systems Lab, ETH Zurich
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Baseline
Anti-snoring Intervention
Arm Description
Participants slept in the anti-snoring bed in the laboratory, but the bed did not provide any intervention
Participants slept in the anti-snoring bed in the laboratory, and the bed moved the trunk of the participant
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04053738
First Posted
August 7, 2019
Last Updated
August 9, 2019
Sponsor
Swiss Federal Institute of Technology
Collaborators
University of Zurich
1. Study Identification
Unique Protocol Identification Number
NCT04053738
Brief Title
The Anti-snoring Bed
Official Title
An Intelligent Bed To Monitor And Reduce Snoring
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Federal Institute of Technology
Collaborators
University of Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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..
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Snoring
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
Participants were not informed prior to going to bed whether the night would be an intervention night or not
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Baseline
Arm Type
No Intervention
Arm Description
Participants slept in the anti-snoring bed in the laboratory, but the bed did not provide any intervention
Arm Title
Anti-snoring Intervention
Arm Type
Experimental
Arm Description
Participants slept in the anti-snoring bed in the laboratory, and the bed moved the trunk of the participant
Intervention Type
Device
Intervention Name(s)
Anti-snoring bed
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effect on snoring
Description
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.
Time Frame
whole night - 4 nights
Secondary Outcome Measure Information:
Title
Self-Reported Sleep Quality
Description
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.
Time Frame
upon awakening - 4 nights
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Riener, Prof. Dr. Dr.-Ing.
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sensory-Motor Systems Lab, ETH Zurich
City
Zurich
ZIP/Postal Code
8092
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
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The Anti-snoring Bed
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