- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02364375
Usability Evaluation of Menai CPAP Masks
Menai Mask Systems - Clinical Study 1
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
The study will evaluate the subjective seal, comfort, stability, usability, and humidification performance of the prototype mask systems in CPAP established patients. The performance of the prototype Menai mask systems (full face, nasal, and pillows variants) will be subjectively assessed through user questionnaires based on an 11-point Likert scale, and will be compared against Comparison masks.
The prototype masks share the same parts (cushion, frame, headgear), with the difference being that the Menai masks feature a novel vent and humidification system.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
New South Wales
-
Sydney, New South Wales, Australien, 2153
- ResMed Sleep Research Centre
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Participants willing to provide written informed consent
- Participants who can read and comprehend written and spoken English
- Participants who are over 18 years of age
- Participants who have been diagnosed with OSA
- Participants who have been established on CPAP for ≥ 6 months
- Participants who are currently using the same mask type/variant as the interventional mask system to be evaluated
Exclusion Criteria:
- Participants who are not able to provide written informed consent
- Participants who are unable to comprehend written and spoken English
- Participants who are pregnant
- Participants who are unsuitable to participate in the study in the opinion of the researcher
- Participants with a pre-existing lung disease or a condition that would predispose them to pneumothorax (e.g. COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection, lung injury)
- Participants who cannot participate for the duration of the trial
- Participants who are established on bi-level support therapy
- Participants who are not currently using the same mask type/variant as the interventional mask system to be evaluated
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Full Face
Participants will trial the same mask type/variant (full face, nasal, pillows) as the variant they are using as part of their current treatment.
Participants in this arm will trial the Menai mask (full face) and Comparison Menai Standard mask (full face) for 7 nights each.
|
Prototype mask system (full face variant) with novel vent and humidification system
Prototype mask system (full face variant) with conventional vent and humidification system
|
Experimentell: Nasal
Participants will trial the same mask type/variant (full face, nasal, pillows) as the variant they are using as part of their current treatment.
Participants in this arm will trial the Menai mask (nasal) and Comparison Menai Standard mask (nasal) for 7 nights each.
|
Prototype mask system (nasal variant) with novel vent and humidification system
Prototype mask system (nasal variant) with conventional vent and humidification system
|
Experimentell: Pillows
Participants will trial the same mask type/variant (full face, nasal, pillows) as the variant they are using as part of their current treatment.
Participants in this arm will trial the Menai mask (pillows) and Comparison Menai Standard mask (pillows) for 7 nights each.
|
Prototype mask system (pillows variant) with conventional vent and humidification system
Prototype mask system (pillows variant) with conventional vent and humidification system
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Usability Performance Evaluation
Tidsram: 2 weeks
|
Evaluation of the usability performance (seal, comfort, etc) of the Menai masks, compared to the Comparison Menai Standard masks.
|
2 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Humidification Performance Evaluation
Tidsram: 2 weeks
|
Evaluation of the humidification performance of the Menai masks (passive humidification), compared to the Comparison Menai Standard masks (active humidification).
|
2 weeks
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Klaus Schindhelm, BE PhD, Graduate School of Biomedical Engineering, University of New South Wales, Sydney Australia and Applied Research, ResMed Ltd Sydney Australia
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MA220115
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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