Sideward Turning Beds for Sleep Apnea
Condition: Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes
Study type: Interventional

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.
    

Detailed description: 
      Obstructive positional sleep apnea

      Obstructive sleep apnea (OSA) is characterised by a repetitive collapse of the upper airway
      during sleep, which results in apnea or hypopnoea associated with oxygen desaturations and
      arousals. OSA affects up to 30% of the adult male population, increases with age, and is
      associated with daytime sleepiness, increased risk of traffic accidents, arterial
      hypertension, vascular dysfunction and cardiovascular events. In 56% to 75% percent of these
      apnea patients, the apnea-hypopnea index is correlating with the body position. This subgroup
      of patients suffers from position-dependent sleep apnea, which is defined by a difference in
      the apnea hypopnea index between supine position and non-supine positions of at least 50%.
      Current treatment recommendation for OSA is continuous positive airway pressure (CPAP)
      ventilation, because of its potential beneficial impact on cardiovascular outcomes. However,
      a recent randomised controlled trial has not shown reduction in major cardiovascular
      endpoints in OSA patients with manifest cardiovascular disease allocated to CPAP. Therefore,
      the beneficial effect of CPAP treatment has been subject to extensive discussion recently.
      Furthermore, in mildly and moderately affected patients, compliance is sometimes limited due
      to various side effects. A valuable alternative, which has been suggested for these patients,
      is the so-called positional therapy. The aim of the therapy is to make the supine position
      uncomfortable so that patients actively avoid it. However, due to interruption of the sleep
      because of acoustic signals or an obstacle fixes at the patients back, current treatment
      options are associated with low long term compliance.

      Mechanisms for turning a sleeping user sideward

      In literature, several mechanisms have been proposed to shift the sleeping user of a bed form
      supine to lateral position. In general, these methods can be sorted into the following four
      categories:

        1. Inclination of one side of the mattress

        2. Tilting of the mattress around a middle axis

        3. Using pressurized air chambers to reconfigure the mattress shape

        4. Using vibration or disturbing stimuli as aversion therapy when the person is sleeping on
           the back Method number 4 does require active participation of the user and would
           therefore have the same limitations as conventional positional therapy. However, method
           1 to 3 are promising candidates for an intelligent anti-sleep apnea bed.

      Methods

      In order to compare the three methods described above a custom-made automated bed that has a
      pressurized air-mattress and provides the ability either to incline half of the bed surface
      up to 70° or tilt the whole surface up to 45° was developed. The purpose of this study is to
      evaluate which of these three mechanisms is more effective in changing the position of the
      user from supine to lateral. Furthermore, the settings which are most likely to induce a
      position change will be determined. In addition, it will be evaluated which test settings
      cause the least arousals in sleeping users. Evaluating this in healthy participants is an
      important step on our way towards an intelligent bed for treatment of position dependent
      obstructive sleep apnea.
    

Intervention name(s): Sidewards Tilting Bed
Intervention type(s): Device
Intervention description(s): Sidewards tilting of the bed is hypothesized to induce a body position change in sleeping subjects.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention