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Donepezil Treatment for Sleep Apnea Patients

Donepezil Treatment for Sleep Apnea Patients: A Double Blind Placebo-Controlled Study

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00912457
Acronym
doneapnea
Enrollment
60
Registered
2009-06-03
Start date
2007-03-31
Completion date
2009-12-31
Last updated
2009-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

sleep apnea, donepezil, pharmacological, cholinergic

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.

Interventions

DRUGdonepezil

donepezil 5 mg/day for 14 days followed by donepezil 10 mg/day for 14 days

DRUGplacebo

placebo 1 p/day for 28 days

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
Associacao Fundo de Incentivo a Psicofarmcologia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
30 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Polysomnography parameters: respiratory parameters, sleep structurebaseline, 28 days, 15 days, 28 days

Secondary

MeasureTime frame
Epworth Sleepiness Scalebaseline, 28 days, 15 days, 28 days

Countries

Brazil

Contacts

Primary ContactLucia Sukys Claudino, MD
lucia@neuromeddiagnosticos.com.br(55-48)-9129-7576
Backup ContactWalter Moraes, MD
walter.moraes@afip.com.br(55-11)-5573-9238

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026