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NCT04925739: NINADOM
Evaluation of the Comfort of a Continuous Positive Airway Pressure Nasal Mask in the Treatment of OSA Syndrome
trial testing Self-questionnaire on the comfort and general appreciation of a nasal mask in Apnea, Obstructive in 20 participants. Completed in 21 January 2022.
21 January 2022
Quick facts
| Lead sponsor | AGIR à Dom |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 22 September 2021 |
| Primary completion | 21 January 2022 |
| Estimated completion | 21 January 2022 |
| Sites | 1 location across France |
Drugs / interventions tested
- Self-questionnaire on the comfort and general appreciation of a nasal mask
- Self-questionnaire on the appearance of CPAP side effects related to the mask
- Self-questionnaire on the patient's appreciation of the mask headgear,
- Self-questionnaire NOSE on the discomfort caused by the nasal obstruction
- Self-questionnaire Epworth on the daytime sleepiness
- To study the CPAP compliance
- To study the unintentional leakage
- To study the therapeutic pressures of CPAP
Conditions studied
- Apnea, Obstructive — all drugs for Apnea, Obstructive →
Sponsor
AGIR à Dom
Who can join
18 and older, any sex, with Apnea, Obstructive. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Continuous positive airway pressure (CPAP) is the first-line treatment for obstructive sleep apnea syndrome (OSA). It consists of a pressure generator connected to a mask applied to the patient's face. CPAP treatment is restrictive, and nearly a quarter of patients abandon it over the long term. Various factors can influence adherence to CPAP therapy, including adverse events associated with the mask. However, it is clear that compliance with CPAP treatment, even if it has tended to improve over the last 30 years, is still sub-optimal. The "Air Liquide Medical Systems" company has developed a mask that aims to improve comfort and ease of use for the patient. This leaky nasal mask has a "silent" intentional leak port, which significantly reduces the noise caused by the escape of air. The noise associated with intentional leakage is one of the discomforts reported by patients and their spouses. In addition, this mask is equipped with a new generation headgear with adjustment indicators to assist the patient in fitting the mask. Optimal headgear fit is a prerequisite for comfort during treatment, as it reduces unintentional leakage. The main objective is to evaluate, through a questionnaire, the comfort and general appreciation of a nasal mask equipped with a silent leak system and a headgear with adjustment aids, of patients with OSA treated with CPAP. Secondary objectives are : 1. To evaluate the appearance of CPAP side effects related to the mask, 2. To collect the patient's appreciation of the mask headgear, 3. To evaluate the discomfort caused by the nasal obstruction reported by the patient, 4. To evaluate the daytime sleepiness of the patient, 5. To study the parameters of the CPAP treatment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04925739
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Apnea, Obstructive
Currently open trials in the same condition.
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- NCT04950894 — Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation · NA · active not recruiting
- NCT04179188 — Impact of Bariatric Surgery in Obese Patients With and Without Obstructive Sleep Apnea Syndrome · recruiting
Other AGIR à Dom trials
Trials by the same sponsor.
- NCT04538274 — Trained Patient Involvement to Promote the Resumption of CPAP in Patients Who Have Discontinued Its Use · NA · not yet recruiting
- NCT05653804 — Impact of Tele-visit on Patients Continous Positive Airway Pressure (CPAP) Follow-up by Home Care Provider · NA · active not recruiting
- NCT05621213 — Satisfaction of Patients With Amyotrophic Lateral Sclerosis Regarding Home Assisted Teleconsultation · NA · terminated
- NCT04716985 — Evaluation of the Daily Intake of 0.5 L of Water Saturated With Molecular Hydrogen for 21 Days in COVID-19 Patients Trea · NA · unknown
- NCT02699918 — Impact of Obstructive SAS on Metastatic Potential of Cutaneous Melanoma · EARLY_PHASE1 · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04925739 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by AGIR à Dom
- Last refreshed: 1 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04925739.
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