Clinical trials: Obstructive Sleep Apnea-hypopnea Syndrome
Obstructive Sleep Apnea, Central Sleep Apnea
Long-term Observation of PAP-therapy With Telemonitoring: Telemedicine Registry TelePAP
Telemonitoring for Positive Airway Pressure (PAP) therapy might help to establish and maintain long-term therapy adherence and thus support the beneficial effects of PAP therapy on long-term outcomes.
- Conditions
- Obstructive Sleep Apnea, Central Sleep Apnea, Mixed Sleep Apnea
- Trial name
- TelePAP (NCT03043716)
- Testing
- PAP therapy with telemonitoring
- Where
- 6 sites in Germany
- Volunteers
- 14,147 people
- Sponsor
- ResMed
Obstructive Sleep Apnea Syndrome
Evaluation of a New Medical Device AL539 in Patients With Obstructive Apneas Sleep Syndrome
Continuous Positive Airway Pressure (CPAP) is the standard treatment in patients with Obstructive Sleep Apnea Syndrome (OSAS). The goal of the study is to evaluate CPAP treatment duration recorded by the AL539 during attended…
- Trial name
- AL539 (NCT01441622)
- Testing
- AL539 (SRETT)
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Air Liquide Santé International
Sleep Apnea, Obstructive, Apnea, Sleep
Study Using Negative Pressure to Reduce Apnea
The objective of this study is to determine the safety and effectiveness of the aerSleep® II device for treatment of moderate to severe Obstructive Sleep Apnea (OSA) over 24 weeks of home use in spontaneously breathing adult…
- Trial name
- SUPRA (NCT04861038)
- Testing
- aerSleep II
- Where
- 15 sites in United States
- Volunteers
- 900 people
- Sponsor
- Sommetrics, Inc.
Obstructive Sleep Apnea
Use of Blood Biomarkers and Biomarker Index to Aid in the Diagnosis of Obstructive Sleep Apnea (OSA)
This multicenter prospective trial will evaluate the association between obstructive sleep apnea (OSA) and blood biomarkers in a representative population of consecutively enrolled symptomatic patients with a clinical suspicion…
- Trial name
- NCT03122483
- Testing
- blood biomarker
- Where
- 3 sites in United States
- Volunteers
- 250 people
- Sponsor
- Beckman Coulter, Inc.
Excessive Daytime Sleepiness
A Clinical Study to Evaluate the Efficacy and Safety of Pitolisant in the Treatment of EDS in Patients With OSA
The objective of this study is to demonstrate the efficacy and safety of pitolisant versus placebo during 12 weeks of the Double Blind period, to treat the Excessive Daytime Sleepiness (EDS) in patients with Obstructive Sleep…
- Trial name
- NCT05223166
- Testing
- Pitolisant
- Where
- China
- Volunteers
- 240 people
- Sponsor
- Citrine Medicine Limited
Obstructive Sleep Apnea (OSA) and Obesity
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of HDM1005 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Receiving Positive Airway Pressure (PAP) Therapy
This is a 56-week randomized, double blinded, parallel-controlled study evaluating the efficacy and safety of the HDM1005 in patients with obstructive sleep apnea (OSA) and obesity receiving positive airway pressure (PAP)…
- Trial name
- NCT07794397
- Testing
- HDM1005
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Obstructive Sleep Apnea (OSA)
Evaluating the Efficacy of PAP Therapy for Treating OSA in the Home Environment
This study will take between 4-6 months (with first patient first visit to last patient last visit expected to span 3-4 months across all study sites).
- Trial name
- NCT04744038
- Testing
- Positive Airway Pressure (PAP) Therapy
- Where
- 2 sites in United States, Australia
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- ResMed
Obstructive Sleep Apnea-hypopnea Syndrome (OSAHS)
Study of the Effect of an Elastic Compression Medical Device, on Water Balance Change in Healthy Subjects
Obstructive sleep apnea-hypopnea syndrome (OSAHS) is characterized by the occurrence of abnormally frequent episodes of interrupted ventilation (apnea) or significant reduction of ventilation (hypopnea) during sleep.
- Trial name
- NCT04911725
- Testing
- Elastic Compression Prototype
- Where
- France
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Laboratoires Innothera
Obstructive Sleep Apnea
CPAP Device In-lab Assessment NZ
The purpose of this trial is to assess device performance against participants in an overnight study to ensure the product meets user and clinical requirements
- Trial name
- NCT02948010
- Testing
- Auto CPAP + comfort feature A, Auto CPAP with comfort feature B, Auto CPAP with no comfort feature
- Where
- New Zealand
- Volunteers
- 104 people
- Sponsor
- Fisher and Paykel Healthcare
Obesity Hypoventilation Syndrome, Obstructive Sleep Apnea
Simplus and Eson Non-Invasive Ventilation (NIV) Evaluation - Germany
This investigation is designed to evaluate the performance, comfort and ease of use of the Simplus and Eson masks amongst NIV patients who are currently on Bi-level therapy
- Conditions
- Obesity Hypoventilation Syndrome, Obstructive Sleep Apnea, Chronic Obstructive Pulmonary Disease, Neuromuscular Disease
- Trial name
- NCT02726048
- Testing
- Simplus/Eson
- Where
- Germany
- Volunteers
- 4 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea of Adult
Pilot Study of the CHILLS Cryotherapy System for the Treatment of OSA
This is a prospective, multicenter, non-randomized single-arm safety and efficacy study to: Collect data to evaluate the safety of CHILLS cryotherapy to treat OSA in patients with moderate to severe disease.
- Trial name
- ARCTIC-2 (NCT05542082)
- Testing
- CHILLS Procedure
- Where
- 2 sites in Panama
- Volunteers
- 22 people
- Sponsor
- Cryosa, Inc.
Obstructive Sleep Apnea
CPAP In-home Assessment USA
The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.
- Trial name
- NCT02809859
- Testing
- Fisher & Paykel Healthcare CPAP Device
- Where
- 4 sites in United States
- Volunteers
- 139 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea, Snoring
A Trial to Evaluate a Device for the Treatment of OSA and Snoring
To evaluate the safety and efficacy of the Tongue Advancement Retainer Device in treating subjects with Obstructive Sleep Apnea (OSA) and snoring.
- Trial name
- OPEN (NCT01772017)
- Testing
- Tongue Advancement Retainer Device
- Where
- 3 sites in United States, Australia
- Volunteers
- 15 people
- Sponsor
- Sleepy, Inc
Obstructive Sleep Apnea
Arousal Analysis by Pulse Wave Amplitude in Patients With Obstructive Sleep Apnea
Photoplethysmography is an easy non-invasive method to detect the pulse wave amplitude (PWA) from a finger. This can be measured using the Somnocheck micro system.
- Trial name
- NCT01690429
- Testing
- Somnocheck micro
- Where
- Germany
- Volunteers
- 26 people
- Sponsor
- Institut für Pneumologie Hagen Ambrock eV
Obstructive Sleep Apnea
Auto Bilevel Adherence Following a Poor Initial Encounter With Continuous Positive Airway Pressure (CPAP)
The primary objective outcome is the proportion of participants compliant (at least four hours of use per night for all nights) in the Auto Bilevel group compared to the continuous positive airway pressure (CPAP) group after 90…
- Trial name
- BiPAPRescue (NCT02522442)
- Testing
- CPAP, Auto BiLevel
- Where
- 3 sites in United States
- Volunteers
- 51 people
- Sponsor
- Philips Respironics
OSA
Long-term Benefits of CPAP or MAD Treatment on the Sleep of OSAS Patients
The REMAP study aims to follow a cohort of 400 patients in around ten sleep centers in France and to collect clinical routine data.
- Trial name
- REMAP (NCT05435794)
- Testing
- CPAP, MAD
- Where
- 9 sites in France
- Volunteers
- 400 people
- Sponsor
- ResMed
Obesity, Overweight
AMAZE 3: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea
This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with excess body weight and obstructive sleep apnoea not treated with positive airway pressure lose weight and improve sleep apnoea.
- Conditions
- Obesity, Overweight, Obstructive Sleep Apnoea
- Trial name
- AMAZE 3 (NCT07571005)
- Testing
- NNC0487-0111
- Where
- 80 sites in United States, Australia and 8 more
- Volunteers
- 300 people
- Sponsor
- Novo Nordisk A/S
Obstructive Sleep Apnea
Stimulation Therapy for Apnea Reduction (Www.theSTARtrial.Com)
The purpose of this clinical trial is to demonstrate long-term safety and efficacy of the Inspire system. The Inspire Upper Airway Stimulation (UAS) therapy is intended to treat moderate-to-severe obstructive sleep apnea by…
- Trial name
- STAR (NCT01161420)
- Testing
- Inspire Upper Airway Stimulation System
- Where
- 22 sites in United States, Belgium and 3 more
- Volunteers
- 929 people
- Sponsor
- Inspire Medical Systems, Inc.
Sleep Apnea, Obstructive
Assessment of PPG & PAT to Detect Upper Airway Obstruction in Patients With Obstructive Sleep Apnea
The goal of this study is to collect raw waveform data for two separate noninvasive methods, both of which may be useful for the assessment of upper airway obstruction.
- Trial name
- NCT01831583
- Testing
- Measurement of PPG waveforms, Measurement of Pulse Arrival Time (PAT)
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Sotera Wireless, Inc.
Obstructive Sleep Apnea
Whitsundays (Nasal) Singapore External Clinical Study 1 Protocol
Each Whitsunday mask or AirFit N30i Quiet mask is worn for 7 nights. The overall purpose of this study is to evaluate the performance of the Whitsundays nasal mask system (a prototype mask) compared to the ResMed AirFit N30i…
- Trial name
- NCT05255744
- Testing
- Positive Airway Pressure (PAP) Therapy
- Where
- Singapore
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- ResMed