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The Anti-snoring Bed

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ClinicalTrials.gov Identifier: NCT04053738
Recruitment Status : Completed
First Posted : August 12, 2019
Last Update Posted : August 12, 2019
University of Zurich
Information provided by (Responsible Party):
Swiss Federal Institute of Technology

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : January 1, 2017
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Snoring

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.

Primary Outcome Measures :
  1. Effect on snoring [ Time Frame: 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 [ Time Frame: 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.

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04053738

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Sensory-Motor Systems Lab, ETH Zurich
Zurich, Switzerland, 8092
Sponsors and Collaborators
Swiss Federal Institute of Technology
University of Zurich
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Principal Investigator: Robert Riener, Prof. Dr. Dr.-Ing. University of Zurich
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Responsible Party: Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT04053738    
Other Study ID Numbers: ASB
First Posted: August 12, 2019    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Sounds
Signs and Symptoms, Respiratory