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Obstructive Sleep ApneaNCT00910195

Validation of a New Automatic Bi-level Algorithm in the Treatment of Sleep-disordered Breathing

A study testing CPAP treatment with subsequent Bi-Level-APAP treatment and Bi-Level-APAP treatment with subsequent CPAP treatment in people with Obstructive Sleep Apnea, run by Wissenschaftliches Institut Bethanien e.V at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Between 2%-4% of adult population suffers from obstructive sleep apnea (OSAS)(1), which is characterized by obstructive snoring, repetitive apnea and hypopnea in sleep, repetitive cyclic oxygen saturation, as a result from sleep fragmentation related to the arousals in sleeping profile and clinical consequences like… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Obstructive Sleep Apnea
What is being tested?
CPAP treatment with subsequent Bi-Level-APAP treatment and Bi-Level-APAP treatment with subsequent CPAP treatment
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteGermany
Study dates
Jun 2008to Apr 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women > 18 years.
  • Newly diagnosed of sleep-apnea-syndrome, AHI> 5 per hour associated with the usual manifestation of this syndrome.
  • Declaration of consent.

Who cannot join

  • Absence of declaration of consent.
  • Other relevant sleep disorders like insomnia, restless legs, parasomnia
  • Heart failure NYHA-CLASS III- IV.
  • Myocardial infarction or unstable angina pectoris or cardiac surgery in within the last three months.
  • Apnea-hypopnea-index < 5 per hour.
  • Pregnancy.
Show all 9Show fewer
  • Malign diseases.
  • Serious chronic oxygen-requiring pulmonary illness.
  • Age under 18 years.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Wissenschaftliches Institut Bethanien e.V.

    Solingen, North Rhine-Westphalia, 42699

Other trials in Germany

About this study

Between 2%-4% of adult population suffers from obstructive sleep apnea (OSAS)(1), which is characterized by obstructive snoring, repetitive apnea and hypopnea in sleep, repetitive cyclic oxygen saturation, as a result from sleep fragmentation related to the arousals in sleeping profile and clinical consequences like day drowsiness, neuropsychological deficits, raised danger of accidents and cardiovascular disease. (1-6). The therapy of choice is the application of nasal continuous positive airway pressure (CPAP) (7-9).

Increasing relevance obtain the combined sleep-related breathing disturbances, where the patient shows an obstructive sleep apnea syndrome and some central breathing disturbances in the polysomnography at night. Those patients frequently present with cardiovascular diseases. These combined night breathing disturbances are frequently insufficient to be mitigated exclusively with a CPAP therapy.

Read more

Some modifications of nCPAP therapy were developed in order to optimize the therapy-compliance and the effectiveness of the therapy. Bi-level-CPAP-devices produce two pressure levels: one for inspiration and another for expiration, so that the patients are able expire against a constant low pressure. An increase in the use of this application in comparison between the conventional or the automatic CPAP therapy could not be proved in early studies. (12, 13) The principle of the automatic nCPAP therapy is to recognize the patient's current need of pressure and to alter the pressure within a set range by applying different algorithms. Some studies have shown that this therapy increased compliance and comfort (14-16), while other studies could not confirm these results. (17, 18)

The result of the current study should prove if the treatment of a new algorithm therapy based on an automatic bi-level-system for patients with sleep-related respiratory disorders is as effectively and subjective more comfortable as the conventional CPAP therapy.

Patients with a particularly high need of pressure should experience a clear expiratory pressure relief and a higher comfort. Therefore a better compliance is to expect. In the same way patients with additional central respiratory disturbances should obtain a benefit from the bi-level modus. This new treatment would help particularly such "critical patients", who are not responding well to the CPAP therapy or find it uncomfortable.

Read the detailed description

Patients who meet all the above mentioned criteria and who were diagnosed as sleep-apnea syndrome patients in our hospital were asked to participate in the study. By a declaration of consent the patients were randomized in two different groups.

Group 1: started with CPAP at the first night and continued with Bi-level- APAP at the second night.

Group 2: began with Bi-level-APAP and ended with CPAP

Patients will be discharged with CPAP after the second night

Being tested
CPAP treatment with subsequent Bi-Level-APAP treatment, Bi-Level-APAP treatment with subsequent CPAP treatment
Keywords
Obstructive sleep apnea, CPAP, Bi-Level
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CPAP treatment with subsequent Bi-Level-APAP treatmentDevice

    CPAP treatment during the first night and then Bi-level-APAP treatment during second night

  • Bi-Level-APAP treatment with subsequent CPAP treatmentDevice

    Bi-level-APAP treatment during the first night and then CPAP treatment during the second night

Study groups in NCT00910195
Study groupRoleWhat they receive
CPAP before Bi-Level-APAPExperimentalreceiving CPAP treatment during the first night and then Bi-level-APAP treatment during second night
Receives: Device: CPAP treatment with subsequent Bi-Level-APAP treatment
Bi-Level-APAP before CPAPExperimentalreceiving Bi-level-APAP treatment during the first night and then CPAP treatment during the second night
Receives: Device: Bi-Level-APAP treatment with subsequent CPAP treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Obstructive and central apnea-hypopnea-Index.

    Measured: day one and two of the study

Secondary outcomes (1)

  1. Total apnea-hypopnea-index, minimum and middle oxygen saturation, subjective satisfaction with the therapy (questionnaire).

    Measured: day one and two of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2009 (estimated)
  2. Study startJun 2008
  3. Primary completionApr 2011
  4. Study completionApr 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Investigator
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00910195
Sponsor's protocol ID
WI_BiLevel APAP_34/2008
Status last verified
Aug 2011
First submitted
28 May 2009
Last updated
9 Aug 2011
Results posted
No
Data monitoring committee
No

Publications

  • Shahar E, Whitney CW, Redline S, Lee ET, Newman AB, Nieto FJ, O'Connor GT, Boland LL, Schwartz JE, Samet JM. Sleep-disordered breathing and cardiovascular disease: cross-sectional results of the Sleep Heart Health Study. Am J Respir Crit Care Med. 2001 Jan;163(1):19-25. doi: 10.1164/ajrccm.163.1.2001008.

    PubMed 11208620

  • Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.

    PubMed 8464434

  • Finn L, Young T, Palta M, Fryback DG. Sleep-disordered breathing and self-reported general health status in the Wisconsin Sleep Cohort Study. Sleep. 1998 Nov 1;21(7):701-6.

    PubMed 11286346

  • Engleman HM, Kingshott RN, Martin SE, Douglas NJ. Cognitive function in the sleep apnea/hypopnea syndrome (SAHS). Sleep. 2000 Jun 15;23 Suppl 4:S102-8.

    PubMed 10893080

  • George CF. Sleep. 5: Driving and automobile crashes in patients with obstructive sleep apnoea/hypopnoea syndrome. Thorax. 2004 Sep;59(9):804-7. doi: 10.1136/thx.2003.007187.

    PubMed 15333860

  • Randerath WJ, Schraeder O, Galetke W, Feldmeyer F, Ruhle KH. Autoadjusting CPAP therapy based on impedance efficacy, compliance and acceptance. Am J Respir Crit Care Med. 2001 Mar;163(3 Pt 1):652-7. doi: 10.1164/ajrccm.163.3.2006168.

    PubMed 11254519

  • Randerath WJ, Galetke W, Ruhle KH. Auto-adjusting CPAP based on impedance versus bilevel pressure in difficult-to-treat sleep apnea syndrome: a prospective randomized crossover study. Med Sci Monit. 2003 Aug;9(8):CR353-8.

    PubMed 12942031

Questions about this trial

What is this clinical trial studying?

A study testing CPAP treatment with subsequent Bi-Level-APAP treatment and Bi-Level-APAP treatment with subsequent CPAP treatment in people with Obstructive Sleep Apnea, run by Wissenschaftliches Institut Bethanien e.V at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Obstructive and central apnea-hypopnea-Index. (time frame: day one and two of the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00910195, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2011.

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