Ergometer Training in Patients With OSA

Obstructive Sleep Apnea Clinical Trial

Official title:

Telemedizinisches Trainings-Monitoring Von Patienten Mit Obstruktivem Schlafapnoesyndrom

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01457729
• Other study ID #: ERGO2011
• Status: Completed
• Phase: N/A
• First received: October 20, 2011
• Last updated: September 17, 2012
• Start date: February 2011
• Est. completion date: December 2011

Study information

• Verified date: September 2012
• Source: Institut für Pneumologie Hagen Ambrock eV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Patients with suspected OSA (obstructive sleep apnoea syndrome) are asked to use a standard bike ergometer which is additionally equipped with a system to gather training data and the ability to send daily training time to an internet server to which the physician has access. Training time of two groups is compared. Group one is not motivated while group two benefits from telephone feedback when training time declines. It is presumed that training time increases with better information and response to training behaviour.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Suspected OSA

2. Capable of giving consent

Exclusion Criteria:

1. Symptomatic cardial infarction

2. Decompensated cardiac insufficiency

3. Hemodynamically effective cardiac arrhythmias

4. Hemodynamically significant Vitia (heart disease)

5. Insufficiently regulated arterial hypertension

6. Global respiratory insufficiency

7. Significant partial insufficiency (PAO2 <50mmHg or SaO2 < 80% at rest)

8. State after decompensation of Cor Pulmonale

9. Right ventricular strain at pulmonary hypertension at rest (pulmonary arterial pressure > 20 mmHg)

10. Severe osteoporosis

11. Higher degree of lung functional restriction: FEV1 <50% oder >60% of nominal value after bronchospasmolysis

12. Working performance on ergometer < 50%

13. Unstable bronchial asthma

14. Exacerbated COPD

15. Heavily overweight (BMI >40 or weight >140kg)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• Motivation by Telephone Call
Telephone call not exceeding 10 minutes according to a protocol

Locations

Country	Name	City	State
Germany	Helios Klinik Hagen Ambrock	Hagen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Institut für Pneumologie Hagen Ambrock eV

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Training time		4 weeks	No