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

NCT00910195 | Completed

• 1 other identifier: WI_BiLevel APAP_34/2008
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 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. 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.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apnea; CPAP; Bi-Level

Outcome Measures

Primary Outcomes (1)

• Obstructive and central apnea-hypopnea-Index.

  day one and two of the study

Secondary Outcomes (1)

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

  day one and two of the study

Study Arms (2)

CPAP before Bi-Level-APAP

EXPERIMENTAL

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

Device: CPAP treatment with subsequent Bi-Level-APAP treatment

Bi-Level-APAP before CPAP

EXPERIMENTAL

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

Device: Bi-Level-APAP treatment with subsequent CPAP treatment

Interventions

CPAP treatment with subsequent Bi-Level-APAP treatment DEVICE

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

CPAP before Bi-Level-APAP

Bi-Level-APAP treatment with subsequent CPAP treatment DEVICE

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

Bi-Level-APAP before CPAP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Malign diseases.
• Serious chronic oxygen-requiring pulmonary illness.
• Age under 18 years.

Sponsors & Collaborators

• Wissenschaftliches Institut Bethanien e.V: lead

Study Sites (1)

Wissenschaftliches Institut Bethanien e.V.

Solingen, North Rhine-Westphalia, 42699, Germany

Location

Related Publications (7)

• 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.

  PMID: 11208620 BACKGROUND

• 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.

  PMID: 8464434 BACKGROUND

• 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.

  PMID: 11286346 BACKGROUND

• 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.

  PMID: 10893080 BACKGROUND

• 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.

  PMID: 15333860 BACKGROUND

• 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.

  PMID: 11254519 BACKGROUND

• 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.

  PMID: 12942031 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Wolfgang Galetke, PD Dr.

  STUDY CHAIR

• Winfried J. Randerath, Prof. Dr.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 28, 2009
• First Posted: May 29, 2009
• Study Start: June 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: August 9, 2011

Record last verified: 2011-08

Locations

DE (1)