- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02245659
Effect of CPAP Treatment on Glycemic Control in Gestational Diabetes: A Pilot Randomized-Controlled Trial
The Effect of Continuous Positive Airway Pressure (CPAP) Treatment on Glycemic Control in Gestational Diabetes: A Pilot Randomized-Controlled Trial
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Gestational diabetes (GDM), defined as glucose intolerance that is first recognized during pregnancy, is associated with adverse maternal and fetal outcomes. Sleep-disordered breathing (SDB) is characterized by breathing pauses during sleep leading to recurrent arousals and intermittent hypoxia. The resulting increases in sympathetic drive, cortisol and inflammation have been shown to lead to glucose dysregulation. In that SDB is prevalent during pregnancy, SDB may represent a novel risk factor for GDM, as suggested by recent observational studies. No interventional studies evaluating the effects of SDB treatment on GDM outcomes have yet been published.
General Objective: To perform a pilot study to assess the feasibility of conducting a randomized-controlled trial using continuous positive airway pressure (CPAP) to evaluate the effects of SDB treatment on maternal-fetal outcomes in GDM.
Primary Aim of Pilot Study: 1) To assess CPAP adherence in pregnant patients with GDM. Secondary Aims: 2) To assess recruitment and retention rates over ~2 months of treatment 3) To assess adequacy of nasal dilator strips as the control intervention 4) To measure maternal glucose levels to determine sample size calculations for a future large-scale multi-site randomized-controlled trial.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Quebec
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Montreal, Quebec, Canada, H4A2Y3
- McGill University Health Centre
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Pregnant women aged ≥ 18 y referred to the GDM clinic at the McGill University Health Centre
- >20 weeks and <34 weeks gestational age at time of recruitment
- Gestational diabetes
- Sleep-disordered breathing (SDB)
Exclusion Criteria:
- Pre-gestational type 1 or type 2 diabetes
- Multiple pregnancy
- Conception by IVF
- Prior treatment for SDB
- severe medical illness
- Severe SDB (AHI >30) and Epworth Sleepiness Scale >15 or oxygen desaturation index >30 or sustained hypoxia < 80%
- Habitual sleep duration on average less than 5 hours/night (determined by actigraphy)
- Cigarette smoking, alcohol consumption or illicit drug use
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: CPAP
|
Continuous Positive Airway Pressure
|
Andet: Nasal dilator strip
Control
|
Nasal dilator strip to be worn nightly
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Average nightly hours of CPAP use
Tidsramme: Up to 8 weeks
|
Calculated over the course of pregnancy, with objective measurement from CPAP device download.
CPAP will be initiated at time of diagnosis of sleep apnea after GDM diagnosis, and up until delivery of the baby (expected duration of 6-8 weeks)
|
Up to 8 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Recruitment and retention rates in trial
Tidsramme: At completion of study (prior to delivery of baby)
|
At completion of study (prior to delivery of baby)
|
|
Maternal glucose levels
Tidsramme: Throughout pregnancy until delivery
|
Continuous glucose monitoring and capillary blood glucose checks
|
Throughout pregnancy until delivery
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metaboliske sygdomme
- Sygdomme i nervesystemet
- Luftvejssygdomme
- Apnø
- Respirationsforstyrrelser
- Søvnforstyrrelser, iboende
- Dyssomnier
- Søvnvågningsforstyrrelser
- Sygdomme i det endokrine system
- Graviditetskomplikationer
- Søvnapnø syndromer
- Diabetes mellitus
- Diabetes, svangerskabssyge
Andre undersøgelses-id-numre
- RN-326488
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Kliniske forsøg med Graviditet
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King's College Hospital NHS TrustEuropean Association for the Study of the LiverRekrutteringCirrhose, lever | HELLP syndrom | Intrahepatisk kolestase af graviditet | Graviditetssygdom | AFLP - Acute Fatty Lever of PregnancyDet Forenede Kongerige
Kliniske forsøg med CPAP
-
State Key Laboratory of Respiratory DiseaseAfsluttetSøvnapnø, obstruktiv | Kontinuerligt positivt luftvejstryk | PolysomnografiKina
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Chinese University of Hong KongAfsluttet
-
University of ZurichSwiss National Science FoundationAfsluttet
-
Ulysses Magalang MDAfsluttetObstruktiv søvnapnøForenede Stater
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The Hospital for Sick ChildrenAfsluttetFedme | Kardiovaskulær sygdom | Obstruktiv søvnapnø | SøvnforstyrrelserCanada
-
Krishna M. SundarAfsluttet
-
University Hospital, GrenobleAfsluttet
-
Queen's UniversityAfsluttetObstruktiv søvnapnø (OSA)Canada
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Fisher and Paykel HealthcareSuburban Lung AssociatesAfsluttetSøvnapnø, obstruktivForenede Stater
-
University Hospital, LilleAfsluttetSøvnapnø syndromer | Epilepsi, DelvisFrankrig