Trial document




drksid header

  DRKS00017471

Trial Description

start of 1:1-Block title

Title

Noticeably better sleep quality is objectively definable: How much steadier and deeper must sleepers breath?

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

Minimal clinically relevant differences of the apnea-hypopnea index

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Many persons suffer from sleeplessness, sleepiness during the day, snoring, and/or further symptoms of a reduced sleep quality. In most cases, an irregular and/or superficial breath during the sleep is the reason. In such cases, the treatment aims at a better oxygenation during the sleep. In mild cases, surgery of the palate and of the tongue base is possible. In more severe cases, a nocturne breathing aid is necessary.

This study investigates how much steadier and deeper the sleep respiration must become in order to alleviate the mentioned symptoms perceptibly. The steadiness and deepness of the sleep respiration is objectively measurable and thus essential for the diagnosis and the evaluation of the progress. However, it is still unknown how much these two important parameters must change in order to become a relevant therapeutic success (or failure). Although physicians and their patients constantly acquire their own personal experience, a communicable quantity allowing a consistent interpretation of comparisons is still missing. With this in mind, it surprises probably little that the classification of a reduced steadiness and deepness of the sleep respiration into degrees of severity is also unclear. Experts hold different Opinions.

The intersection of the personal experiences of the participants of this study leads to a symptom- and thus patient-centred definition of the degrees of severity and of therapeutic success. This facilitates the appraisal of measurement results of follow-ups and of comparisons of different and of new treatments substantially.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Determination of minimal clinically relevant differences for a better evaluation of treatment results of the obstructive sleep apnea.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00017471
  •   2019/07/01
  •   [---]*
  •   yes
  •   Approved
  •   2018-13922, Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1234-9801 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   G47.31 -  [generalization G47.3: Sleep apnoea]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   General information
    • observational study; i.e. only one study arm
    • time points: T0 (day 1), T1 (day 2), T2 (day 50 or 90) und T3 (day 360)
    • primary outcome: subjective rating at T1, T2 and T3 of the impairment by the obstructive sleep apnoea in four categories from „irrelevant“ over „mild“ and „middle“ to „strong“.
    • Predictor: Apnea-Hypopnea Index, which is number of respiratory pauses/reductions per hour of sleep

    Study population
    • eligibility criteria: for the first time diagnosis of an obstructive sleep apnoea at T1, no therapy of the obstructive sleep apnoea before T1, consent into an auto-titrating ventilation
    • further eligibility criteria: see "inclusion criteria" und "exclusion criteria"
    • number of participants: 150 are needed
    • study site: Schlafmedizinisches Zentrum der Hals-Nasen-Ohrenklinik der Universitätsmedizin Mainz

    Implementation
    • written informed consent: at T0 prior to the first polysomnography.
    • data sources: case report forms for the primary outcome (for study purposes only); medical records for all other required data (as part of the clinical routine)
    • data protection: the case report forms are pseudonymous and always remain at the study centre of the department of otorhinolaryngology; in the electronic data set the data are pseudonymous during the validation and afterwards anonymous
    • data quality: weekly validations per routine of the statistics program; as needed followed by inquiries to the participants

    Additional effort for the participants
    The interrogations at T1, T2 and T3 last about 10 minutes each.

    Analysis
    A cut point is determined that classifies changes of the predictor into „relevant“ and „irrelevant“. The classifications of the predictor and the outcome must match as good as possible.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Subjective appraisal at T1, T2, and T3 of the impairment caused by the obstructive sleep apnea; the four categories are "irrelevant", "mild", "middle", and "severe".

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Berlin Snoring Questionnaire, Insomnia Severity Index, Epworth Sleepiness Scale

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2019/07/20
  •   150
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

• Body mass index below 35 kg/m²
• Obstructive sleep apnoea
.. • diagnosed for the first time at T1 at the Sleep Medicine Centre of the Otorhinolaryngology Department of the Mainz University Medical Centre
.. • still untreated at T1
• Consent into an auto-titrating ventilation as part of the routine therapy
• Written informed consent into study participation including
.. • three interviews of 10 minutes each (see “Primary Outcome”)
.. • pseudonymised data electronic storage and validation of personal data

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

• Actual known pregnancy, known cardiac insufficiency, chronic obstructive pulmonary disease stadium III or higher according to GOLD, psychiatric, neurologic or neurodegenerative diseases, narcolepsy or restless-legs syndrome
• Status after apoplexy, myocardial infarction or malign neoplasm
• Further disease that influence the apnoea-hypopnoea-index (predictor) and the sleepiness during the day
• Neuroleptics, antiepileptic drugs, antidepressants, sedatives and further substances that influence the apnoea-hypopnoea-index (predictor) and the sleepiness during the day

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • medscoops - Health Sciences
    • Mr.  Dr.  Rafael  Cámara 
    • Jägerstraße 33
    • 55131  Mainz
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • medscoops - Health Sciences
    • Mr.  Dr.  Rafael  Cámara 
    • Jägerstraße 33
    • 55131  Mainz
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Schlafmedizinischen Zentrum der Hals-Nasen-Ohrenklinik der Universitätsmedizin Mainz
    • Mr.  PD Dr. med.  Haralampos  Gouveris 
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting suspended on temporary hold
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.