Trial document




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  DRKS00004947

Trial Description

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Title

Nightly Hypoxemia in the elderly In-Patient Population and its Correlation to Dementia

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Trial Acronym

NiHyGerDem

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URL of the Trial

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Brief Summary in Lay Language

Investigating the relation of cognitive function in elderly hospital patients and results of nocturnal pulse oximetry and investigation of the effect of oxygen administration on cognitive performance in geriatric hospital patients with sever nocturnal hypoxemia.
In a sugroup of 100 patients with severe hypoxemia oxygen is randomly administerd with a flow of 2I/min or > 4l/min at night. After 10 days of treatment with oxygen a re-test of cognitive function is conducted.

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Brief Summary in Scientific Language

Consecutive geriatric clinic patients with a minimum age of 75 years receive a nightly pulsoxymetry and a comperhensive geriatric assessment that includes assessment of cognitive function.
The data are analyzed in terms of the correlation between the findings of pulsoxymetry and cognitive function.
In a subgroup of 100 patients with severe nocturnal hypoxemia (T90> 30%) nocturnal oxygen will be administered randomnly with two different concentrations (vs. 2l/min.> 4 L / min). Cognitive function will be retested after 10 days of oxygen administration.

The aim of the study is to investigate the correlation between the results of pulse oximetry and cognitive function and the effect of oxygen administration on cognitive function in geriatric patients with severe pre-existing nocturnal hypoxemia.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00004947
  •   2013/05/24
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  •   yes
  •   Approved
  •   51/12, Ethik-Kommission der Universität Ulm
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Secondary IDs

  •   U1111-1143-5029 
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Health Condition or Problem studied

  •   F01 -  Vascular dementia
  •   F02 -  Dementia in other diseases classified elsewhere
  •   F09 -  Unspecified organic or symptomatic mental disorder
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Interventions/Observational Groups

  •   in a subgroup (N=100) of geriatric patients with nocturnal hypoxemia (T90% > 30% of recording time)
    application of oxyigen 2 l/min
  •   geriatric patients with nocturnal hypoxemia (T90% > 30% of recording time)
    application of oxyigen > 4 l/min
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Diagnostic
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Correlation between hypoxemia in the oximetry and cognitive function

In a subgroup of 100 patients with severe hypoxemia and randomnly administered oxygen with 2 l / min (group 1) or > 4l/min (group 2) cognitive function is compared within and between groups using MMSE, test of concentration the elderly (AKT), test of money counting, and trail making test A before and 10 days after oxygen administartion.

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Secondary Outcome

Correlation between nocturnal hypoxemia (T90%) and activities of daily living by means of the barthl-Index at the time of oxymetry and at dischrage of the patient.

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Countries of Recruitment

  •   Germany
  •   China
  •   United States
  •   Japan
  •   Spain
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Planned
  •   2013/06/01
  •   4000
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   75   Years
  •   100   Years
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Additional Inclusion Criteria

geriatric patient in stable clinical state
age > 75 years
willingness to participate
ability to perform a cognitive function test for dementia
physical and mental capability to have a wrist pulsocimetry for at least 3 hours

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Exclusion Criteria

palliative status of disease
dementia beyond the ability to perform a cognitive function test on the level of the MMSE
sleep data recorded before the study
no acceptanc of the oxymeter device
unwillingness to participate in the study

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik Ghersburg Hermann Buhl Institut
    • Mr.  PD. Dr. med  Nikolaus  Netzer 
    • Ghersburgstr. 9
    • 83043  Bad Aibling
    • Germany
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    • Kliniken Essen Mitte Zentrum für Altersmedizin
    • Mr.  Dr. med.  Helmut  Frohnhofen 
    • Am Deimelsberg 34a
    • 45276  Essen
    • Germany
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    • Klinik Ghersburg Hermann Buhl Institut
    • Mr.  PD. Dr. med  Nikolaus  Netzer 
    • Ghersburgstr. 9
    • 83043  Bad Aibling
    • Germany
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    • Klinik Ghersburg Hermann Buhl Institut
    • Mr.  PD. Dr. med  Nikolaus  Netzer 
    • Ghersburgstr. 9
    • 83043  Bad Aibling
    • Germany
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Sources of Monetary or Material Support

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    • Klinik Ghersburg Hermann Buhl Institut
    • Mr.  PD. Dr. med  Nikolaus  Netzer 
    • Ghersburgstr. 9
    • 83043  Bad Aibling
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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