Sleep Apnea Clinical Trial
Official title:
Randomized Control Trial to Compare Patient Outcomes Following Unattended Polysomnography Versus In-lab Polysomnography for Sleep Apnea and Comorbid Sleep Disorders
This randomized controlled study will directly evaluate whether unattended polysomnography (level 2 sleep study) in individuals referred for sleep apnea or hypersomnia, including those with comorbidities of insomnia and sleep-related movement disorders, provides similar patient outcomes when compared to level 1 sleep studies.
Individuals referred to the Sleep Disorder Centre with a major complaint of snoring or, apneas or hypersomnia, with at least one additional minor concern of snoring, apneas, restless leg syndrome or insomnia, will be considered for entry into the study. Using a randomized controlled trial design, study participants will be randomly assigned to either the intervention group who will undergo a full unattended polysomnography (level 2 home sleep study) using the Prodigy portable wireless sleep monitor or in-lab polysomnography (level 1 sleep study). Other aspects of care including the clinical assessment will be equivalent between groups. A randomly assigned sleep specialist physician will make treatment recommendations to the patient based on the sleep study results and determine the need for a subsequent testing (including repeat sleep studies) as part of each patient encounter. Physicians participating in the study will receive an introduction to the Odds Ratio Product (ORP) and training on its diagnostic potential. Diagnostic confidence using a 5 point Likert scale from 10% (very unsure) to 90% (very confident) will be assessed after each sleep study review. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05582070 -
Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction
|
N/A | |
| Recruiting |
NCT03919955 -
A Novel Pharmacological Therapy for Obstructive Sleep Apnea
|
Phase 2 | |
| Completed |
NCT03927547 -
Sleep Disordered Breathing and Cardiopulmonary Disease in Peruvian Highlanders
|
N/A | |
| Recruiting |
NCT04007380 -
Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI
|
N/A | |
| Completed |
NCT02188498 -
Electrocardiography Data Analysis in Sleep Disorders
|
||
| Completed |
NCT01503164 -
Effects of Continuous Positive Airway Pressure (CPAP) on Glucose Metabolism
|
N/A | |
| Recruiting |
NCT00747890 -
Surgical Treatment of Mild Obstructive Sleep Apnea
|
N/A | |
| Active, not recruiting |
NCT00738179 -
Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea to Prevent Cardiovascular Disease
|
Phase 3 | |
| Completed |
NCT00841906 -
Alice PDx User/Validation Extended Trial
|
N/A | |
| Completed |
NCT00202501 -
Usefulness of Nasal Continuous Positive Airway Pressure (CPAP) Treatment in Patients With a First Ever Stroke and Sleep Apnea Syndrome
|
N/A | |
| Completed |
NCT00047463 -
Effects of Treating Obstructive Sleep Apnea in Epilepsy
|
Phase 2 | |
| Not yet recruiting |
NCT06029881 -
Portable System for Non-intrusive Monitoring of Sleep
|
||
| Recruiting |
NCT06093347 -
Central Apnoea Monitor Study
|
||
| Terminated |
NCT05445869 -
Severe OSA Study (SOS)
|
N/A | |
| Withdrawn |
NCT04096261 -
The Importance of Sleep Quality and the Blood-brain Barrier in Cognitive Disorders and Alzheimer's Disease
|
||
| Recruiting |
NCT04575740 -
Phenotyping Mechanistic Pathways for Adverse Health Outcomes in Sleep Apnea
|
N/A | |
| Completed |
NCT04676191 -
Validation of a Contactless Vital Signs Measurement Sensor
|
N/A | |
| Recruiting |
NCT06015620 -
Comorbidities Resolution After MGB Surgery and Change in Body Composition
|
||
| Completed |
NCT06051097 -
Metabolic Syndrome and Obstructive Sleep Apnea
|
||
| Completed |
NCT05687097 -
Untreated Sleep Apnea as an Aggravating Factor for Other Secondary Medical Conditions After Spinal Cord Injury
|