Sideward Turning Beds for Sleep Apnea

NCT04265118 | Completed

• 1 other identifier: SideBed
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this feasibility study is to compare different settings of a custom-made automated bed with respect to their ability to induce a change in the sleeping position of the user. In particular, it is of interest whether the bed mechanism is able to change the position of a user from supine to lateral position. At the same time, the investigators want to know whether the intervention provided by the bed results in an arousal in sleeping users. In addition, feasibility of detecting the position of the user using the un-obtrusive pressure sensors, which are integrated in the bed, will be assessed. Within the experiment, the investigators will identify participants that are sleeping mainly in supine position by doing an acti-watch based screening measurement in their home setting. Those participants who are sleeping in supine position for more than 12.5% of the home recording with the acti-watch will be invited to come to the lab for one night measurement. The experimenter will trigger interventions of the bed manually when the participant is lying in supine position. The investigators will evaluate the position change using infrared cameras and the built in sensors of the bed. Furthermore, a commercially available home-measurement device to record polysomnography will be used to evaluate whether the intervention caused arousals.

Conditions

Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• Change in position of the upper body

  Change in the position of the upper body in degree of turning around the longitudinal axis (derived from infrared Video and from bodyworn position sensor)

  1 year

• Arousals from sleep

  Change of the orientation of the upper body assessed with the polysomnography device (asleep)

  1 year

Secondary Outcomes (1)

• Performance of the sensors

  1 year

Study Arms (1)

Sideward Tilt of Bed

EXPERIMENTAL

During sleep, while lying in supine position, the participant will be tilted sidewards by the bed. In practice, the experimenter activates the bed at timepoints during the night where the participant is lying in supine position. Activating the bed results in one half of the bed lifting 10 to 40 Degrees sidewards.

Device: Sidewards Tilting Bed

Interventions

Sidewards Tilting Bed DEVICE

Sidewards tilting of the bed is hypothesized to induce a body position change in sleeping subjects.

Sideward Tilt of Bed

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• % of the sleep in the screening night spent in supine position.

You may not qualify if:

• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
• Injuries or pain that prevents sleeping in supine or lateral position.
• Pregnancy.
• Length longer than 2 m (larger than standard bed).
• investigators, their family members, employees and other dependent persons\^.

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead

Study Sites (1)

SMS lab

Zurich, 8092, Switzerland

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Robert Riener, Prof. Dr.

  Swiss Federal Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 11, 2020
• Study Start: March 10, 2020
• Primary Completion: July 19, 2020
• Study Completion: July 19, 2020
• Last Updated: August 3, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: The data will be ulpoaded to the research collection after study completion and is available there for a period of 15 years.
• Access Criteria: Open Access

Locations

CH (1)