Obstructive Sleep Apnea (OSA), Sleepiness, and Activity in Diabetes Management (OSA_DM)
OSA, Sleepiness, and Activity in Diabetes Management
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
-
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Pennsylvania
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Pittsburgh, Pennsylvania, Spojené státy, 15261
- University of Pittsburgh
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: 1 subjects treated with CPAP
Continuous Positive Airway Pressure treatment (CPAP)
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Mask worn over nose to splint open the airway with positive pressure to prevent the subject from holding their breath (apneas).
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Falešný srovnávač: 2 subjects treated with sham-CPAP
Sham Continuous Positive Airway Pressure treatment (sham-CPAP)
|
Mask worn over nose to splint open the airway with positive pressure to prevent the subject from holding their breath (apneas).
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Physical Activity, Steps Walked
Časové okno: after one-month treatment
|
Steps walked measured by the Bodymedia SenseWear Pro Armband®Data collected from the main study period
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after one-month treatment
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Fructosamine
Časové okno: after one-month
|
Change in fructosamine level from baseline to one month: data from main study period
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after one-month
|
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Change in Sleep Quality
Časové okno: 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
Časové okno: after one month
|
Daytime Sleepiness measured by the Epworth Sleepiness Scale; measured from 0 to 24; higher scores indicate worse sleepiness
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after one month
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Change in Vigor-Activity During Main Study Period
Časové okno: 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
|
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Fatigue/Inertia
Časové okno: after one month
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Fatigue/Inertia from the Profile of Moods Subscale; scores range from 0 to 28; higher scores indicate more fatigue/inertia
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after one month
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Eileen R. Chasens, DSN, University of Pittsburgh
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Poruchy metabolismu glukózy
- Metabolické choroby
- Nemoci nervového systému
- Nemoci dýchacích cest
- Poruchy dýchání
- Poruchy spánku, vnitřní
- Dysomnie
- Poruchy spánku a bdění
- Onemocnění endokrinního systému
- Příznaky a symptomy, Respirační
- Syndromy spánkové apnoe
- Spánková apnoe, obstrukční
- Diabetes Mellitus
- Diabetes mellitus, typ 2
- Apnoe
- Ospalost
Další identifikační čísla studie
- R21HL089522-01A2 (Grant/smlouva NIH USA)
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