Obstructive Sleep Apnea Clinical Trial
Official title:
Effect of Increasing Respiratory Drive on Severity of Obstructive Apnea
Verified date | September 2013 |
Source | University of Manitoba |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
This study is being conducted to determine whether inhaling exhaled carbon dioxide is effective for the treatment of sleep apnea. A mild increase in this gas can stimulate the respiratory drive by 2-3 fold, which in turn can stimulate the upper airway dilator muscles and decrease the severity of obstructive sleep apnea by at least 50% in selected patients.
Status | Terminated |
Enrollment | 13 |
Est. completion date | June 2015 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Moderate to severe OSA Apnea Hypopnea Index > 20/hr. - Minimum oxygen saturation by pulse oximetry (SpO2) during events >70% throughout sleep during the clinical sleep study Exclusion Criteria: - Neuromuscular disease. - Obesity-hypoventilation syndrome. - Chronic obstructive pulmonary disease. - Pregnancy. - Significant comorbidities: 1. Dialysis-dependant renal failure 2. Severe asthma 3. Congestive 4. Heart failure 5. Previous stroke - Recent (within 3 months) myocardial infarction or Active coronary ischemia event. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Misericordia Medical Centre, Sleep Disorder Centre | Winnipeg | Manitoba |
Canada | Sleep Disorder Centre at Misericordia Health Centre | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University of Manitoba |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in total Apnea-hypopnea index (AHI) | We expect that at least half the patients will undergo >50% reduction in their AHI relative to the control part of the study. The baseline apnea-hypopnea index will be established during the sham intervention, and will be compared to the AHI at the end of the CO2 rebreathing intervention. | Eight to ten hours. Within the same study night, the AHI will be compared at baseline and at the end of the intervention period | No |
Secondary | Sleep quality as assessed by Total Sleep Time. Sleep Efficiency, and Arousal Index | The sleep architecture assessed by the sleep efficiency, number of arousals and awakenings, and the time awake after sleep onset (WASO) will be determined at baseline (sham) and compared after CO2 rebreathing intervention. If the apnea/hypopnea index is improved, the sleep quality is expected to improve accordingly, however, the intervention itself has the potential to disrupt sleep even when only minor changes in CO2 are expected. | Eight to ten hours. Within the same study night, the sleep quality conventional measurements will be compared at baseline and at the end of the intervention period | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05857384 -
Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs
|
Phase 1 | |
Recruiting |
NCT04547543 -
Follow-up of Apneic Patients by Visio-consultation
|
N/A | |
Recruiting |
NCT05371509 -
Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study
|
N/A | |
Completed |
NCT02515357 -
Mediterranean Diet/Lifestyle Intervention in Obstructive Sleep Apnea
|
N/A | |
Completed |
NCT05582070 -
Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction
|
N/A | |
Active, not recruiting |
NCT03189173 -
Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea
|
Phase 2 | |
Completed |
NCT04084899 -
The Effect of CPAP on Lung Hyperinflation in Patients With OSA
|
||
Completed |
NCT03032029 -
Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
|
||
Recruiting |
NCT04028011 -
Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea
|
||
Recruiting |
NCT06047353 -
Community Health Advocates for Motivating PAP Use in Our Neighborhoods.
|
N/A | |
Completed |
NCT05253963 -
Acute Effect of CPAP on Weight in Patients With Obstructive Sleep Apnea
|
N/A | |
Recruiting |
NCT06029959 -
Stroke and CPAP Outcome Study 3
|
N/A | |
Recruiting |
NCT06150352 -
Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
|
||
Completed |
NCT03589417 -
Postural Stability, Balance and Fall Risk in Patients With Obstructive Sleep Apnea
|
||
Recruiting |
NCT04335994 -
ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing
|
N/A | |
Withdrawn |
NCT04063436 -
Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea
|
N/A | |
Recruiting |
NCT05385302 -
Sociological Determinants of Positive Airway Pressure Adherence in OSA Patients
|
||
Recruiting |
NCT04572269 -
Metabolomics of Obstructive Sleep Apnea
|
||
Not yet recruiting |
NCT06467682 -
12-week Tele-exercise Program in Patients With OSA
|
N/A | |
Withdrawn |
NCT04011358 -
Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study
|
N/A |