Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-01-27 @ 3:45 AM
Study NCT ID:
NCT00912457
Status:
UNKNOWN
Last Update Posted:
2009-06-03
First Post:
2009-06-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Donepezil Treatment for Sleep Apnea Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077265', 'term': 'Donepezil'}], 'ancestors': [{'id': 'D007189', 'term': 'Indans'}, {'id': 'D007192', 'term': 'Indenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-06-02', 'studyFirstSubmitDate': '2009-06-02', 'studyFirstSubmitQcDate': '2009-06-02', 'lastUpdatePostDateStruct': {'date': '2009-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Polysomnography parameters: respiratory parameters, sleep structure', 'timeFrame': 'baseline, 28 days, 15 days, 28 days'}], 'secondaryOutcomes': [{'measure': 'Epworth Sleepiness Scale', 'timeFrame': 'baseline, 28 days, 15 days, 28 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['sleep apnea', 'donepezil', 'pharmacological', 'cholinergic'], 'conditions': ['Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '22281004', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nIntervention: 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."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of obstructive sleep apnea according to American Academy of Sleep Medicine criteria\n\nExclusion Criteria:\n\n* body mass index \\> 40\n* use of psychoactive drugs\n* presence of neurological, cardiological and pulmonary diseases'}, 'identificationModule': {'nctId': 'NCT00912457', 'acronym': 'doneapnea', 'briefTitle': 'Donepezil Treatment for Sleep Apnea Patients', 'organization': {'class': 'OTHER', 'fullName': 'Associacao Fundo de Incentivo a Psicofarmcologia'}, 'officialTitle': 'Donepezil Treatment for Sleep Apnea Patients: A Double Blind Placebo-Controlled Study', 'orgStudyIdInfo': {'id': 'CEP0043/07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Donepezil', 'description': 'Donepezil-treated sleep apnea patients', 'interventionNames': ['Drug: donepezil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo-treated sleep apnea patients', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'donepezil', 'type': 'DRUG', 'otherNames': ['Eranz, Aricept'], 'description': 'donepezil 5 mg/day for 14 days followed by donepezil 10 mg/day for 14 days', 'armGroupLabels': ['Donepezil']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['Non-active substance'], 'description': 'placebo 1 p/day for 28 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04020-060', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Lucia Sukys-Claudino, MD', 'role': 'CONTACT', 'email': 'lucia@neuromeddiagnosticos.com.br', 'phone': '(55-48)-9129-7576'}, {'name': 'Walter Moraes, MD, PhD', 'role': 'CONTACT', 'email': 'walter.moraes@afip.com.br', 'phone': '(55-11)-5573-9238'}, {'name': 'Sergio Tufik, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dalva Poyares, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Instituto do Sono / Associacao Fundo de Incentivo a Psicofarmacologia', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Lucia Sukys Claudino, MD', 'role': 'CONTACT', 'email': 'lucia@neuromeddiagnosticos.com.br', 'phone': '(55-48)-9129-7576'}, {'name': 'Walter Moraes, MD', 'role': 'CONTACT', 'email': 'walter.moraes@afip.com.br', 'phone': '(55-11)-5573-9238'}], 'overallOfficials': [{'name': 'Walter Moraes, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associacao Fundo de Incentivo a Psicofarmcologia'}, {'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', 'affiliation': 'AFIP/ UNIFESP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Associacao Fundo de Incentivo a Psicofarmcologia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Walter Andre dos Santos Moraes', 'oldOrganization': 'AFIP'}}}}