Obstructive Sleep Apnea SyndromeNCT00936286
Respiratory Muscle Training in Obstructive Sleep Apnea Syndrome (OSAS) Patients
A study testing SpiroTiger in people with Obstructive Sleep Apnea Syndrome, run by Idiag AG at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether respiratory muscle training by means of normocapnic hyperpnea leads to clinical and polysomnographical improvements in patients with mild to intermediate sleep apnea syndrome. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- SpiroTiger
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2009to Mar 2010
- 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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to intermediate sleep apnea syndrome with AHI of 10 - 30/h and clinical symptoms
- Refusal of a primary nCPAP therapy
- Epworth Sleepiness Scale (ESS) score ≥ 9
- Signed informed consent form
Who cannot join
- Therapy with pharmaceuticals which can influence the musculature
- Psychiatric disease which negatively influences compliance
- Acute and chronic diseases of the lung and/or the respiratory passages
- BMI ≥ 35 kg/m²
Trial locations and contacts
1 site in 1 country.
Germany1 site
Wissenschaftliches Institut Bethanien e.V.
Solingen, North Rhine-Westphalia, 42699
About this study
Official title: The Impact of Respiratory Muscle Training on the Therapy of Obstructive Sleep Apnea Syndrome (OSAS) Patients
The purpose of this study is to determine whether respiratory muscle training by means of normocapnic hyperpnea leads to clinical and polysomnographical improvements in patients with mild to intermediate sleep apnea syndrome.
Read the detailed description
The obstructive sleep apnea syndrome (OSAS) is of great significance for affected individuals as well as for public health service. Patients suffer from reduced quality of life and show an increased accident risk in road traffic and on the job. Furthermore, OSAS represents an independent risk factor for cardiovascular diseases, in particular arterial hypertension.
In sleep apnea patients, the relatively early stimulation of the upper respiratory tract muscles compared to the thoracic respiratory muscles is abrogated in many cases. Alternatively, nerve damage with impaired sensory function in the pharynx area and impaired motor function of the upper air tract musculature, in particular the musculus genioglossus can be observed. The disturbed sensory function impairs the reflex activation of the genioglossus. Moreover, the pattern of neurogenic muscle damage with a loss of the pattern of different types of fibers changed to the point of adjoining atrophic and hypertrophic sections and a more monotonous appearance of fiber types could be detected. During waking hours the activity of the musculus genioglossus is enhanced compared with control persons, which is interpreted as a compensatory mechanism. During sleep time, however, this compensation seems to disappear.
In several studies either direct or indirect stimulation of the musculus genioglossus and its supplying nerves were deployed. Yet, the results were inconsistent. The direct muscle stimulation using intramuscular electrodes, although efficient, was no longer pursued due to technical reasons. Although the results of an external stimulation showed improvements regarding apneas and snoring, the findings were usually weakly pronounced. In a study ascertaining muscle training with transcutaneous electrical stimulation a significant improvement regarding snoring was achieved when compared to placebo. In general, no influence on sleep apnea syndrome could be accomplished, although there were individual cases showing a clinically relevant amelioration.
A preceding study compared habitual snorers with control persons. It was shown that respiratory muscle training by means of normocapnic hyperpnea was accompanied by enlargement of the musculus genioglossus and reduced snoring. Moreover, an increased physical performance was observed.
Thus, the question arises if training of the respiratory musculature by means of normocapnic hyperpnea leads to clinical and polysomnographical improvements in patients with mild to intermediate sleep apnea syndrome.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- SpiroTiger
- Keywords
- Obstructive Sleep Apnea Syndrome, Respiratory Muscle Training, Normocapnic Hyperpnea, SpiroTiger, Polysomnography
- 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.
SpiroTigerDevice
Also called SpiroTiger Medical
Respiratory muscle training with SpiroTiger device, 1 week training initiation and 4 weeks training period with 5 training days per week, training duration 30 min each. Respiratory bag volume set at 50% VC, respiratory frequency starting from 50% MVV. Weekly control trainings.
| Study group | Role | What they receive |
|---|---|---|
| Respiratory Muscle Training | Experimental | Not described Receives: Device: SpiroTiger |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea index, Snoring
Measured: 5 weeks
Secondary outcomes (4)
Polysomnography (PSG) with sleep stages, total arousal count and respiratory arousal count
Measured: 5 weeks
Clinical symptoms according to self-assessment questionnaire (Epworth Sleepiness Scale)
Measured: 5 weeks
Lung function test parameters (VC, FEV1, MVV, etc.)
Measured: 5 weeks
Nocturnal partial pressure of oxygen and/or carbon dioxide in the blood (during PSG)
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Idiag AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Winfried J. Randerath, Prof. Dr., Study chair, Wissenschaftliches Institut Bethanien e.V
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936286
- Sponsor's protocol ID
- WI_SpiroTiger_87/2008
- Status last verified
- Mar 2010
- First submitted
- 7 Jul 2009
- Last updated
- 10 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Herkenrath SD, Treml M, Priegnitz C, Galetke W, Randerath WJ. Effects of respiratory muscle training (RMT) in patients with mild to moderate obstructive sleep apnea (OSA). Sleep Breath. 2018 May;22(2):323-328. doi: 10.1007/s11325-017-1582-6. Epub 2017 Oct 28.
PubMed 29080065
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Respiratory Muscle Training on the Therapy of Obstructive Sleep Apnea Syndrome (OSAS) Patients
- ClinicalTrials.gov ID
- NCT00936286
- Acronym / sponsor ID
- WI_SpiroTiger_87/2008
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- Obstructive Sleep Apnea Syndrome, Respiratory Muscle Training, Normocapnic Hyperpnea, SpiroTiger, Polysomnography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Idiag AGIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 10 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether respiratory muscle training by means of normocapnic hyperpnea leads to clinical and polysomnographical improvements in patients with mild to intermediate sleep apnea syndrome.
Detailed description
The obstructive sleep apnea syndrome (OSAS) is of great significance for affected individuals as well as for public health service. Patients suffer from reduced quality of life and show an increased accident risk in road traffic and on the job. Furthermore, OSAS represents an independent risk factor for cardiovascular diseases, in particular arterial hypertension.
In sleep apnea patients, the relatively early stimulation of the upper respiratory tract muscles compared to the thoracic respiratory muscles is abrogated in many cases. Alternatively, nerve damage with impaired sensory function in the pharynx area and impaired motor function of the upper air tract musculature, in particular the musculus genioglossus can be observed. The disturbed sensory function impairs the reflex activation of the genioglossus. Moreover, the pattern of neurogenic muscle damage with a loss of the pattern of different types of fibers changed to the point of adjoining atrophic and hypertrophic sections and a more monotonous appearance of fiber types could be detected. During waking hours the activity of the musculus genioglossus is enhanced compared with control persons, which is interpreted as a compensatory mechanism. During sleep time, however, this compensation seems to disappear.
In several studies either direct or indirect stimulation of the musculus genioglossus and its supplying nerves were deployed. Yet, the results were inconsistent. The direct muscle stimulation using intramuscular electrodes, although efficient, was no longer pursued due to technical reasons. Although the results of an external stimulation showed improvements regarding apneas and snoring, the findings were usually weakly pronounced. In a study ascertaining muscle training with transcutaneous electrical stimulation a significant improvement regarding snoring was achieved when compared to placebo. In general, no influence on sleep apnea syndrome could be accomplished, although there were individual cases showing a clinically relevant amelioration.
A preceding study compared habitual snorers with control persons. It was shown that respiratory muscle training by means of normocapnic hyperpnea was accompanied by enlargement of the musculus genioglossus and reduced snoring. Moreover, an increased physical performance was observed.
Thus, the question arises if training of the respiratory musculature by means of normocapnic hyperpnea leads to clinical and polysomnographical improvements in patients with mild to intermediate sleep apnea syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respiratory Muscle Training | Experimental | Device: SpiroTiger |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mild to intermediate sleep apnea syndrome with AHI of 10 - 30/h and clinical symptoms
- Refusal of a primary nCPAP therapy
- Epworth Sleepiness Scale (ESS) score ≥ 9
- Signed informed consent form
Key exclusion criteria (4 listed)
- Therapy with pharmaceuticals which can influence the musculature
- Psychiatric disease which negatively influences compliance
- Acute and chronic diseases of the lung and/or the respiratory passages
- BMI ≥ 35 kg/m²
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpiroTigerAlso: SpiroTiger MedicalRespiratory muscle training with SpiroTiger device, 1 week training initiation and 4 weeks training period with 5 training days per week, training duration 30 min each. Respiratory bag volume set at 50% VC, respiratory frequency starting from 50% MVV. Weekly control trainings. | Device | Respiratory Muscle Training |
Primary outcome
Apnea-hypopnea index, Snoring
Time frame: 5 weeks
4 secondary outcomes
Polysomnography (PSG) with sleep stages, total arousal count and respiratory arousal count
Time frame: 5 weeks
Clinical symptoms according to self-assessment questionnaire (Epworth Sleepiness Scale)
Time frame: 5 weeks
Lung function test parameters (VC, FEV1, MVV, etc.)
Time frame: 5 weeks
Nocturnal partial pressure of oxygen and/or carbon dioxide in the blood (during PSG)
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2010.
- Derived from this study: PubMed 29080065Herkenrath SD, Treml M, Priegnitz C, Galetke W, Randerath WJ. Effects of respiratory muscle training (RMT) in patients with mild to moderate obstructive sleep apnea (OSA). Sleep Breath. 2018 May;22(2):323-328. doi: 10.1007/s11325-017-1582-6. Epub 2017 Oct 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winfried J. Randerath, Prof. Dr. study chair
Wissenschaftliches Institut Bethanien e.V
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SpiroTiger in people with Obstructive Sleep Apnea Syndrome, run by Idiag AG 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 4 inclusion and 4 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 10 Mar 2010. 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?
Apnea-hypopnea index, Snoring (time frame: 5 weeks). 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 NCT00936286, which also lists 1 linked publication.
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 10 Mar 2010.