Clinical trial NCT00912457: Donepezil Treatment for Sleep Apnea Patients
Official title: Donepezil Treatment for Sleep Apnea Patients: A Double Blind Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Obstructive Sleep Apnea
Keywords: sleep apnea
donepezil
pharmacological
cholinergic
Lead sponsor: Associacao Fundo de Incentivo a Psicofarmcologia
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2009-06-03
Enrollment: 60
Sex: MALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* diagnosis of obstructive sleep apnea according to American Academy of Sleep Medicine criteria

Exclusion Criteria:

* body mass index \> 40
* use of psychoactive drugs
* presence of neurological, cardiological and pulmonary diseases

Primary outcomes:
measure: Polysomnography parameters: respiratory parameters, sleep structure
timeFrame: baseline, 28 days, 15 days, 28 days
Secondary outcomes:
measure: Epworth Sleepiness Scale
timeFrame: baseline, 28 days, 15 days, 28 days
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto do Sono / Associacao Fundo de Incentivo a Psicofarmacologia
Study officials:
affiliation: Associacao Fundo de Incentivo a Psicofarmcologia
name: Walter Moraes, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: AFIP / UNIFESP
name: Lucia Sukys-Claudino, MD
role: STUDY_DIRECTOR
affiliation: AFIP/ UNIFESP
name: Dalva Poyares, MD, PhD
role: STUDY_CHAIR
affiliation: AFIP/ UNIFESP
name: Sergio Tufik, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.