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Obstructive Sleep Apnea (OSA), Sleepiness, and Activity in Diabetes Management (OSA_DM)

6. november 2017 oppdatert av: Eileen R. Chasens

OSA, Sleepiness, and Activity in Diabetes Management

Daily physical activity is important to achieve glucose control in persons with type 2 diabetes. The purpose of this study is to explore if obstructive sleep apnea and its daytime symptom, excessive sleepiness, act as barriers to physical activity. We will examine if treatment of obstructive sleep apnea with continuous positive airway pressure results in increased physical activity in persons with type 2 diabetes.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Obstructive sleep apnea (OSA) is a serious disorder characterized by episodic obstruction of the pharyngeal airway accompanied by cessation or reduction in airflow. Untreated OSA has a negative impact 24 hours a day, disrupting nighttime sleep and causing excessive daytime sleepiness that interferes with functioning. Recent studies suggest that OSA and type 2 diabetes (T2DM) not only co-exist but that OSA may adversely affect glucose homeostasis. While physical activity is recognized as beneficial to persons with T2DM, OSA severity or daytime sleepiness may act to hinder persons with T2DM from participating in physical activity. The primary aim of this pilot/feasibility study is to obtain preliminary data to facilitate further hypothesis development and enhance the feasibility of conducting a double blind, randomized, placebo-controlled study to examine physical activity in subjects with T2DM and OSA who are treated with CPAP compared to subjects on sham-CPAP. The secondary aims are to explore: 1) the interrelationships of OSA severity, daytime sleepiness, and physical activity on glucose variability at baseline; 2) average pre-post therapy changes in glucose variability in subjects treated with CPAP compared to subjects receiving sham-CPAP, and 3) pre to post therapy changes in weight, diet, residual sleepiness and mood in subjects treated with CPAP compared to subjects receiving sham-CPAP.

The primary endpoint of the study, physical activity, will be measured by the Bodymedia SenseWear Pro Armband® to determine activity counts. The endpoint for glucose variability will be measured by the Medtronic Continuous Glucose Monitoring System (CGMS). Adherence to CPAP will be measured by a Smart Card® inserted in subjects' CPAP machines. We will limit the sample of subjects who are randomized to CPAP or sham-CPAP to persons with an adequate sleep duration pre-treatment (> 6 hours), with moderate or severe OSA and with EDS to have a more homogenous, profoundly affected sample for this pilot study. The information that will result from the proposed study on of the effect of OSA and EDS on glucose variability has the potential to lead to the development of improved behavioral interventions in persons with diabetes. In addition, this study contains measures of diet and mood to begin to elucidate the possible effects of OSA and EDS on diabetes management.

Studietype

Intervensjonell

Registrering (Faktiske)

23

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15261
        • University of Pittsburgh

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • T2DM (verified by primary care provider (PCP) or medication for T2DM)
  • AHI (from PSG) greater than > 15
  • A1c < 9.0%
  • Epworth Sleepiness Sca;e > 10 (Baseline Assessment)
  • Able to ambulate independently or with a cane
  • Age 40-65 years
  • BMI< 45
  • No acute medical and psychiatric illness in past 3 months
  • Self-reported sleep duration of at least 6 hours
  • No changes in medications, including diabetic medications, in last 3 months
  • Telephone access
  • Able to perform study tests (e.g., speak, read and write in English)
  • Willing to be randomized to CPAP or sham-CPAP

Exclusion Criteria:

  • Diagnosis of another sleep disorder, in addition to OSA,
  • Oxygen or Bi-level positive airway pressure required for treatment of OSA
  • An oxygen saturation <75% for >10% of the diagnostic PSG or if subject has oxygen saturation <75% for >25% of the first 4 h of the diagnostic PSG
  • Any individual in the household currently or with history of CPAP treatment
  • Type 1 or gestational diabetes
  • Prescribed insulin for treatment of type 2 diabetes
  • Regular use (> 3 times/week) of hypnotic or alerting medications
  • History of a near-miss or automobile accident due to sleepiness
  • Employed in transportation-related safety sensitive occupation such as an airline pilot, truck driver, or train engineer
  • Currently working night or rotating shifts
  • Routine consumption of alcohol as determined by >2 drinks day
  • Known allergy to medical adhesives or dermatological conditions that would preclude wearing CGMS
  • Swim or water aerobics >once a week
  • Participation in contact sports or activity that may damage CGMS device or cause injury from monitor
  • Claustrophobia that prevents wearing the CPAP mask
  • Pregnancy

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 1 subjects treated with CPAP
Continuous Positive Airway Pressure treatment (CPAP)
Enhet: Continuous Positive Airway Pressure (CPAP)
Mask worn over nose to splint open the airway with positive pressure to prevent the subject from holding their breath (apneas).
Sham-komparator: 2 subjects treated with sham-CPAP
Sham Continuous Positive Airway Pressure treatment (sham-CPAP)
Enhet: Sham- Continuous Positive Airway Pressure (Sham-CPAP)
Mask worn over nose to splint open the airway with positive pressure to prevent the subject from holding their breath (apneas).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Physical Activity, Steps Walked
Tidsramme: after one-month treatment
Steps walked measured by the Bodymedia SenseWear Pro Armband®Data collected from the main study period
after one-month treatment

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Fructosamine
Tidsramme: after one-month
Change in fructosamine level from baseline to one month: data from main study period
after one-month
Change in Sleep Quality
Tidsramme: after one month
From Pittsburgh Sleep Quality Index; scores range from 0 to 21 with higher scores worse sleep quality; data from main study period
after one month
Change in Daytime Sleepiness During Main Study Period
Tidsramme: after one month
Daytime Sleepiness measured by the Epworth Sleepiness Scale; measured from 0 to 24; higher scores indicate worse sleepiness
after one month
Change in Vigor-Activity During Main Study Period
Tidsramme: after one month
Vigor-Activity from Profiles of Mood Scale; scores range from 0 to 32 with higher scores indicating higher vigor/activity
after one month
Fatigue/Inertia
Tidsramme: after one month
Fatigue/Inertia from the Profile of Moods Subscale; scores range from 0 to 28; higher scores indicate more fatigue/inertia
after one month

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Eileen R. Chasens

Etterforskere

  • Hovedetterforsker: Eileen R. Chasens, DSN, University of Pittsburgh

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2009

Primær fullføring (Faktiske)

1. april 2012

Studiet fullført (Faktiske)

1. april 2012

Datoer for studieregistrering

Først innsendt

3. desember 2008

Først innsendt som oppfylte QC-kriteriene

3. desember 2008

Først lagt ut (Anslag)

4. desember 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. november 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. november 2017

Sist bekreftet

1. november 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • R21HL089522-01A2 (U.S. NIH-stipend/kontrakt)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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