The Evaluation of a New Nasal Mask for the Treatment of Obstructive Sleep Apnea
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a nasal, sub-nasal or pillows mask will be recruited.
The study will involve a baseline (Visit 1) data gathering with the participant's PAP therapy and their usual mask. This will be followed by the participants being fitted with the trial nasal mask by a mask fitting expert for use in-home (Visit 2). There will be a follow up phone call to gain feedback or address any issues after 3±1 days. The participant will then come in to return the mask (Visit 3) and give feedback on their experience using the mask in home in the form of a structured interview during Visit 3. If the participants prefer the trail nasal mask they will be asked if they would like to continue using the trial mask for a further six months in-home. There will be a follow up monthly phone call to gain feedback or address any issues during the extension. At the end of the six month extension period, the participants will return the trial nasal mask to the institution and give feedback on their experience using the mask in home in the form of a self-administered questionnaire. Participants will revert to their usual masks thereafter. Neither the participants nor the investigators will be blinded to the study.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Missouri
-
Saint Louis, Missouri, Forente stater, 63143
- Clayton Sleep Institute
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Diagnosis of OSA by Physician
- ≥ 22 years of age
- ≥ 66 lbs
- Prescribed PAP or BPAP therapy for OSA
- Existing nasal, sub-nasal and pillows mask users
- Fluent in written and spoken English
Exclusion Criteria:
- Inability to give informed consent
- Pregnant or think they may be pregnant
- PAP Intolerant
- Anatomical or Physiological Conditions that make PAP inappropriate
- IPAP pressure of ≤25cmH20.
- PAP/BPAP therapy device without data recording capabilities
- Using a PAP/BPAP therapy device for the delivery any medication with the exception of oxygen
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Experimental: Experimental trial nasal mask
Experimental trial nasal mask: Participants will be placed on this arm for a total of 14±3 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.
Participants on the extension will use this trial mask for a further six months after Visit 3.
|
This trial nasal mask will serve as the participant's primary PAP/BPAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3).
For participants taking part in the study extension, they will be using the trial nasal mask as their primary PAP/BPAP therapy mask for 6 months after Visit 3.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants Objective Trial Mask Performance
Tidsramme: 14 ± 3 days in home
|
Objective measure (determined from efficacy data recorded from the participants PAP/BPAP therapy device. Adequate therapy was evaluated by reviewing the Apnea Hypopnea Index (AHI) at baseline to intervention within each individual participants from their PAP therapy device reports. Maintenance of therapy was determined by evaluating the change in AHI. The below data demonstrates how many participants of the analyzed population demonstrated maintenance of therapy after using the new F&P nasal mask. |
14 ± 3 days in home
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants Trial Mask Overall Simplicity of Use
Tidsramme: 14 ± 3 days in home
|
Determined from questionnaires - Subjective (uses a 5-point Likert scale measuring ease of use, from very simple, simple, average, challenging, very challenging).
Results below represent percentage of respondents for each value.
|
14 ± 3 days in home
|
|
Number of Participants Subjective Trial Mask Comfort
Tidsramme: 14 ± 3 days in home
|
Determined from questionnaires - Subjective (uses a 5-point Likert scale measuring comfort from very comfortable, comfortable, average, uncomfortable, very uncomfortable).
Participants reported their subject views on mask comfort.
Responses to each likert scale option are presented below as percentages.
|
14 ± 3 days in home
|
|
Number of Participants Overall Trial Mask Satisfaction
Tidsramme: 14 ± 3 days in home
|
Determined from questionnaires and a sleep diary - Subjective (measuring overall mask satisfaction, includes discussion, questions around overall satisfaction and preference of the new F&P Nasal mask compared to participants' usual mask ).
|
14 ± 3 days in home
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Mark Muehlbach, Clinical Director
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CIA-262
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
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