Trial document





This trial has been registered retrospectively.
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  DRKS00007705

Trial Description

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Title

Follow-up of PAP treated OSA patients in their home environment – a comparative study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Purpose: Regular follow-up sleep studies of patients who are suffering from repetetive nightly breathing pauses, and which are treated with breathing therapy equipment, are clinically important since sleep apnea can still deteriorate and leave the patient insufficiently treated. Sleep lab based check-up for follow-up is expensive, time-consuming and has long waiting times thus the use of at home ambulatory devices is a viable and practical approach. This study aims to assess the comfort and efficacy of a new portable monitoring device with less sensors than the generally used 6 channel devices, such as the Embletta PDS, in terms of follow-up diagnosis of residual breathing pauses in treated patients.
Methods: Forty-nine subjects, using PAP-therapy to treat OSA for at least 6 months, underwent home sleep studies on two consecutive nights with either the new device, WP200, first and the standard device, Embletta, second or vice versa. Subjects completed a satisfaction questionnaire to assess the comfort of both devices. The recordings of both devices were compared in regard to respiratory and desaturation events.

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Brief Summary in Scientific Language

Purpose: Follow-up sleep study of PAP-treated OSA patients is clinically important since OSA can still deteriorate and leave the patient insufficiently treated. Sleep lab based PSG for follow-up is expensive, time-consuming and has long waiting times thus the use of at home ambulatory devices is a viable and practical approach. This study aims to assess the comfort and efficacy of a portable monitoring device based on Peripheral Arterial Tonometry -WatchPAT-200 (WP200) in comparison to Embletta PDS, a regularly used six channel polygraph, in terms of follow-up diagnosis of obstructive sleep apnea (OSA) in PAP-treated patients.
Methods: Forty-nine subjects (39 male, mean ± SD age, 66.3 ± 10.5 years; body mass index, 30.5 ± 5.3 kg/m2), using PAP to treat OSA for at least 6 months, underwent home sleep studies on two consecutive nights with either WP200 first and Embletta second or vice versa. Subjects completed a modified PSQ-18 questionnaire and scored a “school grade” (i.e. 1-6, which corresponds to grades A-F) to assess the comfort of both devices. The recordings of both devices were automatically analyzed, and Embletta recordings were also visually scored according to AASM criteria 2012.
Results: In terms of comfort patients clearly favored the WP200 over Embletta. In terms of efficacy WP200 and Embletta showed low to moderate agreement for AHI and ODI respectively, using Bland-Altman analysis and intra-class correlation. WP200 tended to score higher rates of respiratory events than Embletta, which may be related to the fact that WP calculates AHI based on total sleep time rather than total recording time as does the Embletta. Also, on average WP200 scored ODI lower than Embletta.
Conclusion: The WP200 may offer a simple, comfortable and accurate ambulatory method for the follow-up of PAP treated OSA patients.

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Organizational Data

  •   DRKS00007705
  •   2015/01/20
  •   [---]*
  •   yes
  •   Approved
  •   EA1/084/12, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   G47.31 -  [generalization G47.3: Sleep apnoea]
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Interventions/Observational Groups

  •   patients use the WatchPAT-200 for one night at home
  •   patients use the Embletta PDS for one night at home
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Diagnostic
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

patient satisfaction with the home testing sleep devices regarding the comfort, assessed by a modified PSQ-18 questionnaire, which has to be completed after each measurement

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Secondary Outcome

efficacy of the WatchPAT in comparison to Embletta PDS in regard to AHI and ODI

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2012/09/14
  •   49
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

presence of previous diagnosed OSA (AHI >5 events/hour); current regular PAP use for at least 6 months

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Exclusion Criteria

severe psychiatric disorders; severe neurological disorders; PAP noncompliance; history of peripheral vascular disease; finger deformity that precludes adequate WP200 sensor application

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Addresses

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    • Charité- Universitätsmedizin Berlin, CCM-CC11,Interdisziplinäres Schlafmedizinisches Zentrum
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité-Universitätsmedizin Berlin, CCM-CC11, Interdisziplinäres Schlafmedizinisches Zentrum
    • Mr.  Prof. Dr.  Thomas  Penzel 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité-Universitätsmedizin Berlin, CCM-CC11, Interdisziplinäres Schlafmedizinisches Zentrum
    • Ms.  Stefanie  Knorre 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Charité- Universitätsmedizin Berlin, CCM-CC11, Interdisziplinäres Schlafmedizinisches Zentrum
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    •   [---]*
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    • Itamar Medical LTD.
    • 30889  Caesarea
    • Israel
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2013/06/07
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* This entry means the parameter is not applicable or has not been set.