A Trial to Evaluate a Device for the Treatment of OSA and Snoring (OPEN)
22. november 2015 opdateret af: Sleepy, Inc
A Multi Center, Open Label Study to Evaluate a Tongue Advancement Retainer Device in the Treatment of Subjects With Obstructive Sleep Apnea and Snoring (OPEN Trial)
To evaluate the safety and efficacy of the Tongue Advancement Retainer Device in treating subjects with Obstructive Sleep Apnea (OSA) and snoring.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The Tongue Advancement Retainer Device is a device that was developed to treat subjects with OSA and snoring.
The purpose of this study is to evaluate initial safety and effectiveness of this device in treating one or both conditions.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
15
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
New South Wales
-
St. Leonards, New South Wales, Australien, 2065
- Royal North Shore Hospital
-
-
-
-
California
-
San Diego, California, Forenede Stater, 92120
- Senta Clinic
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Visalia, California, Forenede Stater, 93291
- Visalia Medical Clinic
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
• Aged 18-65
- AHI greater than or equal to 10 but less than or equal to 60 (<10 AHI <60/hr)
- Complete set of lower anterior incisors with no evidence of periodontal disease or mobility and the ability to floss between teeth
Additionally subjects will in the screening phase must:
- Tolerate the device when being fitted
- Used the device for >4 hours on at least two consecutive nights during the screening period.
- Be able to reliably demonstrate proper installation of the device after fitting.
- Be willing to trial the device for a 4 week period
Exclusion Criteria:
• Central sleep apnea events >10% of the total events
- Evidence of Cheyne stokes breathing
- Currently on treatment for OSA or OSA treatment discontinued less than 3 months prior.
- Currently on regular treatment with prescription hypnosedatives or prescription stimulants
- Very severe OSA, defined as AHI>60/hour and/or minimum oxygen saturation <75%
- Need for immediate initiation of treatment as assessed by physician (e.g. Excessive sleepiness posing driving risk)
- Previous surgery to treat OSA (other than nasal surgery)
- Evidence of periodontal disease or tooth mobility
- Severe nasal obstruction or enlarged tonsils based on clinical assessment
- Unstable cardiovascular disease (untreated hypertension acceptable).
- Inability to tolerate oral device due to oral condition or claustrophobia as determined by the study investigator
- Pregnant/Breast Feeding
- Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as co-existent other sleep disorder, psychiatric disease, history of non compliance to medical regimens, or unwillingness to comply with study requirements.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Device Treatment
Tongue Advancement Retainer Device
|
Tongue Advancement Retainer Device
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Primary Safety Endpoint - The safety of the device will be measured through recorded observations of adverse events.
Tidsramme: Approximately 6 weeks
|
Safety endpoint will be measured throughout the duration of the study.
|
Approximately 6 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Primary Efficacy Endpoint - Change in the overall Apnea Hypopnea Index (AHI) from the PSG at baseline and end of treatment phase.
Tidsramme: Approximately 6 weeks
|
Efficacy Endpoint will be measured at baseline and at end of treatment.
|
Approximately 6 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Brian Weeks, MD, Senta Clinic
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2012
Primær færdiggørelse (Faktiske)
1. august 2013
Studieafslutning (Faktiske)
1. august 2013
Datoer for studieregistrering
Først indsendt
30. oktober 2012
Først indsendt, der opfyldte QC-kriterier
16. januar 2013
Først opslået (Skøn)
21. januar 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
24. november 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. november 2015
Sidst verificeret
1. november 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- OPEN-002
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .