NCT03070756

Brief Summary

This study implements an extended (post marked) examination of the efficacy of a proactive auto-CPAP algorithm, which is based on the forced oscillation technique (FOT) in a sample of patients with predominantly obstructive sleep apnea. The auto-CPAP algorithm examined in this study is implemented in the medical devices prisma20A and prismaLAB (Löwenstein Medical Technology).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 6, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

December 29, 2017

Status Verified

December 1, 2017

Enrollment Period

1.3 years

First QC Date

August 9, 2016

Last Update Submit

December 27, 2017

Conditions

Obstructive Sleep Apnea

Keywords

auto-CPAPforced oscillation techniqueobstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

  • Apnea-Hypopnea Index (AHI /h TST)

    number of apneas and hypopneas per hour of sleep time (TST)

    2 days: change from recorded AHI in diagnostic PSG-acquistion to recorded AHI in treatment PSG-acquistion

Secondary Outcomes (11)

  • Obstructive Apnea-Hypopnea Index (oAHI /h TST)

    2 days: diagnostic and treatment PSG-acquistion

  • Obstructive Apnea Index (oAI /h TST)

    2 days: diagnostic and treatment PSG-acquistion

  • Central Apnea-Hypopnea Index (cAHI /h TST)

    2 days: diagnostic and treatment PSG-acquistion

  • Oxygen Desaturation Index (ODI /h TST)

    2 days: diagnostic and treatment PSG-acquistion

  • Arousal Index (ArI /h TST)

    2 days: diagnostic and treatment PSG-acquistion

  • +6 more secondary outcomes

Study Arms (1)

treatment group (auto-CPAP)

OTHER

Participants of this study undergo an diagnostic PSG night. The diagnostic night is followed by an auto-CPAP treatment night. Interventions: The treatment night is in line with the routine procedure of the laboratory except the following intervention: the device settings for the treatment night are applied according to the study protocol (minimal intervention).

Device: Minimal-Intervention - Specification of device settings

Interventions

Minimal-Intervention - Specification of device settingsDEVICE

\- device settings for auto-CPAP treatment night: therapy mode=APAP, Pmin=5hPa,Pmax=20 hPa, Soft-Start duration \<=15 min, softPAP Level is selected based on patient comfort

Also known as: Specification of device settings
treatment group (auto-CPAP)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Apnea-Hypopnea Index (AHI) \> 15,0 (n/h Total Sleep Time)
  • Initial diagnosis of predominant obstructive sleep apnea (percentage of central respiratory events \< 20 %)
  • informed written consent

You may not qualify if:

  • missing informed written consent
  • Participation in another clinical trial that influences the initiation of auto-CPAP treatment by specifications of device settings or titration procedure
  • acute cardiac decompensation
  • severe arrhythmia
  • severe hypotension, particularly in combination with intravascular volume depletion
  • severe epistaxis
  • high risk of barotrauma
  • decompensated pulmonary conditions
  • pneumothorax or pneumomediastinum
  • pneumocephalus
  • cranial trauma
  • status following brain surgery or surgical intervention on the pituitary gland or the middle/inner ear
  • acute sinus infection (sinusitis), middle ear infection (otitis media) or perforated eardrum
  • dehydration
  • Data of patients who completed the study protocol will be excluded from statistical analysis if one of the following criteria applies:
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wissenschaftliches Institut Bethanien e.V.

Solingen, 42699, Germany

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Winfried J. Randerath, Professor

    Wissenschaftliches Institut Bethanien e.V

    STUDY DIRECTOR

Central Study Contacts

Regina Schäfer

CONTACT

004972182830regina.schaefer@loewensteinmedical.de

Alexander Grimm

CONTACT

004972182830alexander.grimm@loewensteinmedical.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2016

First Posted

March 6, 2017

Study Start

October 1, 2016

Primary Completion

January 1, 2018

Study Completion

March 1, 2018

Last Updated

December 29, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)