Clinical trials: Sleep Hypopnea
OSA
Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo)
This is a Phase 3 Randomized Double-Blind Placebo-Controlled 1-year Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.
- Trial name
- NCT05811247
- Testing
- AD109
- Where
- 64 sites in United States
- Volunteers
- 660 people
- Sponsor
- Apnimed
Sleep Apnea, Obstructive
Obstructive Sleep Apnea (OSA) Treated With a Potassium Channel Inhibitor
The aim of this study in subjects with obstructive sleep apnea is to investigate pharmacodynamics, safety and tolerability after a single nasal administration of BAY2253651 and to evaluate first safety and tolerability of…
- Trial name
- SANDMAN (NCT03603678)
- Testing
- BAY2253651
- Where
- 2 sites in Switzerland, United Kingdom
- Volunteers
- 34 people
- Sponsor
- Bayer
Obstructive Sleep Apnea
Evaluation of the F&P Toffee Nasal Pillows Mask, US, 2022
The purpose of this clinical investigation is to evaluate the performance and safety of the F\&P Toffee nasal pillows mask in a home environment.
- Trial name
- NCT05573763
- Testing
- F&P Toffee
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Fisher and Paykel Healthcare
Sleep Apnea
Validation of Software for Assessment of Sleep Apnea From Data Acquired by a Wearable Smartwatch
This clinical validation study aims to evaluate the utility of Fitbit's Sleep Apnea Alert software for minimally invasive monitoring of sleep apnea events to alert users of their risk of sleep apnea.
- Trial name
- NCT03775291
- Testing
- Simultaneous assessment of sleep apnea by polysomnogram and wearable device
- Where
- 6 sites in United States, Ireland
- Volunteers
- 303 people, healthy volunteers welcome
- Sponsor
- Fitbit LLC
Sleep Apnea
A Study of Danavorexton (TAK-925) in Adults With Obstructive Sleep Apnea
The main aim of the study is to check the side effects from overnight treatment with danavorexton and assess the tolerability of varying doses of danavorexton administered intravenously.
- Trial name
- NCT05180890
- Testing
- Danavorexton
- Where
- Australia
- Volunteers
- 13 people
- Sponsor
- Takeda
Obstructive Sleep Apnea
KPAP vs EPR for Comfort
The KPAP EPR Home is a randomized, crossover study in which subjective comfort will be compared between SleepRes APAP + KPAP and ResMed APAP + EPR.
- Trial name
- NCT07530510
- Testing
- APAP + KPAP, APAP + EPR
- Volunteers
- 24 people
- Sponsor
- SleepRes Inc.
Sleep-Disordered Breathing
Polysomnography Validation of the Sansa Device
The objective of this study is to evaluate the performance of the Sansa device for the diagnosis of sleep disordered breathing.
- Trial name
- NCT06070389
- Testing
- Sansa device
- Where
- 2 sites in United States
- Volunteers
- 533 people, healthy volunteers welcome
- Sponsor
- Huxley Medical, Inc.
Narcolepsy, Obstructive Sleep Apnea
SUNOSI® (Solriamfetol) Pregnancy Registry
The SUNOSI (solriamfetol) Pregnancy Registry is a US- and Canada-based prospective, observational study to evaluate the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep…
- Conditions
- Narcolepsy, Obstructive Sleep Apnea, Pregnant Women and Their Offspring
- Trial name
- NCT06413420
- Testing
- Sunosi (solriamfetol), Other prescription wake-promoting medications or stimulants, No treatment
- Where
- 2 sites in United States
- Volunteers
- 1,731 people
- Sponsor
- Axsome Therapeutics, Inc.
Sleep Disordered Breathing (SDB), Sleep Apnea
Neurostimulation for Sleep Disordered Breathing
This is a first in human study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing.
- Trial name
- ECLIPSE 1 (NCT06883617)
- Testing
- Neuro stimulator Implant
- Where
- Paraguay
- Volunteers
- 45 people
- Sponsor
- Lunair Medical
Sleep Disordered Breathing, Cheyne-Stokes Respiration
Feasibility Study to Determine the Effects of Phrenic Nerve Stimulation in Patients With Periodic Breathing
The purpose of this feasibility study is to determine the effect of stimulating the phrenic nerve to treat periodic breathing (a pattern of breathing characterized by hyperpneas followed by hypopneas or apneas).
- Conditions
- Sleep Disordered Breathing, Cheyne-Stokes Respiration, Sleep Apnea
- Trial name
- NCT00909259
- Testing
- Phrenic stimulation device
- Where
- 5 sites in United States, China and 1 more
- Volunteers
- 50 people
- Sponsor
- Respicardia, Inc.
Sleep Apnea
Rainbow Acoustic Monitoring (RAM) Clinical Engineering Data Collection
To capture high resolution waveform data and numerical data from investigational and FDA-released RAM sensors in the neonatal, infant, pediatric, and adult patient population
- Trial name
- NCT03120897
- Testing
- RAM sensor
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- Masimo Corporation
Patients with Mild Obstructive Sleep Apnea Hypopnea
A Clinical Pharmacology Study of TS-142 in Patients with Obstructive Sleep Apnea Hypopnea.
A study to evaluate the respiratory safety of TS-142 in patients with mild obstructive sleep apnea hypopnea.
- Trial name
- NCT04746105
- Testing
- TS-142
- Where
- Japan
- Volunteers
- 46 people
- Sponsor
- Taisho Pharmaceutical Co., Ltd.
Obstructive Sleep Apnea
Investigating a Wrist-sensor Oximeter to Screen for Sleep Apnoea.
The primary study objective is to investigate sensitivity and specificity of a wrist sensor pulse oximeter (the Oxitone Medical Oxitone 1000M device) to screen for obstructive sleep apnoea.
- Trial name
- NCT04018547
- Testing
- Patient wears a wrist sensor oximeter device for one to two nights.
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Oxitone Medical Ltd.
Obstructive Sleep Apnea
TPAP for Comfort in OSA
TheraPAP is a prototype device (with full documented electrical and isolation safety) being developed by SleepRes for the treatment of obstructive sleep apnea (OSA) that can deliver either standard CPAP at a set pressure or what…
- Trial name
- NCT06264128
- Testing
- TPAP, CPAP
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- SleepRes Inc.
Cardiovascular Diseases, Cardiovascular Diseases Risk
Cor360: Clinician-Facing Broad-Spectrum Cardiac Phenotyping and Risk Assessment Using COR® Wearable ECG to Inform Outcomes-Oriented Care Pathways
Cor360 is an observational study evaluating whether extended wearable electrocardiogram (ECG) data can support broad-spectrum cardiac phenotyping and risk assessment beyond conventional single-purpose ambulatory rhythm…
- Conditions
- Cardiovascular Diseases, Cardiovascular Diseases Risk, Cardiac Conduction System Disease, Bundle/Fascicular Abnormalities
- Trial name
- Cor360 (NCT07775976)
- Testing
- COR Wearable ECG Monitoring, Cor360 Clinician-Facing Decision-Aid Reporting
- Where
- 2 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Peerbridge Health, Inc
Obstructive Sleep Apnea
Study of a Sleep Apnea System for the Treatment of Obstructive Sleep Apnea
This is a prospective study of the Attune Sleep Apnea System for the treatment of obstructive sleep apnea. The objective of the study is to demonstrate safety and effectiveness of the Attune Sleep Apnea System to support FDA…
- Trial name
- ATLAST (NCT01146782)
- Testing
- Attune Sleep Apnea System
- Where
- 6 sites in United States
- Volunteers
- 367 people
- Sponsor
- ApniCure, Inc.
Obstructive Sleep Apnoea (OSA)
Assessment of the Performance of a New Reduced Noise Mask Vent
As continuous positive airway pressure is the treatment of choice for OSA, a mask is vital in ensuring the effectiveness of therapy delivery. The study will evaluate the performance and usability of the new mask vent.
- Trial name
- NCT01575210
- Testing
- CPAP mask
- Where
- Australia
- Volunteers
- 31 people
- Sponsor
- ResMed
Obstructive Sleep Apnea, Hypertension
A Study to Assess the Efficacy and Safety of Lorundrostat in Participants With Obstructive Sleep Apnea and Hypertension
The primary purpose of the study is to assess the effect of lorundrostat taken orally (po) once a day on the Apnea-Hypopnea Index (AHI) in participants with moderate to severe obstructive sleep apnea (OSA) and hypertension.
- Trial name
- NCT06785454
- Testing
- Lorundrostat
- Where
- 27 sites in United States
- Volunteers
- 48 people
- Sponsor
- Mineralys Therapeutics Inc.
Snoring, Obstructive Sleep Apnea
Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) Obstructive Sleep Apnea Syndrome (OSAS)
Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) for the Treatment of Snoring and Obstructive Sleep Apnea Syndrome (OSAS): A Pilot Study.
- Trial name
- NCT03640793
- Testing
- Implantation
- Where
- Switzerland
- Volunteers
- 25 people
- Sponsor
- Medartis AG
Sleep Apnea, Central, Sleep Apnea, Obstructive
Evaluation of ApneaLink Plus Scoring Capabilities
The purpose of this study is to investigate the following topics: Determine the accuracy of ApneaLink Plus in separating Apneas into Obstructive Apneas, Mixed Apneas and Central Apneas.
- Trial name
- NCT00823134
- Testing
- ApneaLink Plus
- Where
- Germany
- Volunteers
- 23 people
- Sponsor
- ResMed