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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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The purpose of this study is to determine the effects of the anticholinesterase drug donepezil on sleep apnea patients. Sleep structure and respiratory parameters will be analyzed by polysomnography.
Cholinergic activity also influences the upper airway opening via central and peripheral mechanisms. Decreased thalamic pontine cholinergic projections may affect respiratory drive leading to both central and obstructive apnea at least in certain degenerative conditions.In contrast to the prolific literature on physical and surgical treatments for sleep apnea there is a dearth of effective pharmacological approaches.Most drugs previously tested for this purpose acted upon monoaminergic and adenosinergic systems and showed unsuccessful or ambiguous results.A previous study showed that donepezil treatment improved apnea-hypopnea index and oxygen saturation in patients with Alzheimer's disease. Treatment also increased REM sleep duration and reduced ADAS-cog scores.Based on these facts we hypothesize that donepezil treatment may be beneficial for sleep apnea patients.
Intervention: Patients will be administered donepezil or placebo. The study has a randomized, double-blind placebo-controlled design. Complete polysomnography will be performed at baseline, after 28 days of drug or placebo treatment, after 15 days drug or placebo washout and after 28 days of CPAP treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Donepezil | Experimental | Donepezil-treated sleep apnea patients |
|
| Placebo | Placebo Comparator | Placebo-treated sleep apnea patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| donepezil | Drug | donepezil 5 mg/day for 14 days followed by donepezil 10 mg/day for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Polysomnography parameters: respiratory parameters, sleep structure | baseline, 28 days, 15 days, 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Epworth Sleepiness Scale | baseline, 28 days, 15 days, 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucia Sukys Claudino, MD | Contact | (55-48)-9129-7576 | lucia@neuromeddiagnosticos.com.br | |
| Walter Moraes, MD | Contact | (55-11)-5573-9238 | walter.moraes@afip.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Walter Moraes, MD PhD | Associacao Fundo de Incentivo a Psicofarmcologia | Principal Investigator |
| Lucia Sukys-Claudino, MD | AFIP / UNIFESP | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto do Sono / Associacao Fundo de Incentivo a Psicofarmacologia | Recruiting | São Paulo | São Paulo | 04020-060 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22281004 | Derived | Sukys-Claudino L, Moraes W, Guilleminault C, Tufik S, Poyares D. Beneficial effect of donepezil on obstructive sleep apnea: a double-blind, placebo-controlled clinical trial. Sleep Med. 2012 Mar;13(3):290-6. doi: 10.1016/j.sleep.2011.09.014. Epub 2012 Jan 26. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| placebo | Drug | placebo 1 p/day for 28 days |
|
|
| Dalva Poyares, MD, PhD |
| AFIP/ UNIFESP |
| Study Chair |
| Sergio Tufik, MD, PhD | AFIP/ UNIFESP | Study Chair |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |