A randomized, four-way cross-over, double-blind, controlled study of oral donepezil (2, 5, 10 mg) in patients with moderate to severe obstructive sleep apnea.

Active, not recruiting

• Conditions: Moderate to severe obstructive sleep apnea. Males and females; aged 25 to 65 years, previously diagnosed OSA defined as an oxygen desaturation (4%) index of 15 or more per hour of sleep obtained from a preceding routine outpatient screening recording.

• Registration Number: EUCTR2005-003789-40-SE
• Lead Sponsor: Pharmapnea AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Eligible for this study are patients who meet each one of the following criteria at the screening visit.
-Males and females; age 25 to 65 years
-Previously diagnosed OSA defined as an oxygen desaturation (4%) index of 15 or more obtained from a preceding routine outpatient screening recording. The screening study had to encompass at least 6 hours overnight recording of SaO2, respiratory movements (impedance), heart rate, nasal and oral airflow, breathing sounds, and body position.
-The patient is able to read and understand the patient information sheet.
-The patient has given signed informed consent before any study specific procedures are carried out.
-The patient is willing to attend the study appoints in the correct time window.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients who meet one or more of the following criteria at the screening visit or at Visit 2 on Day 1 cannot be selected:

1.Previous exposure to continuous positive airway pressure (CPAP treatment) or oral devices is allowed but treatment has to be interrupted at least one week before the first study night and throughout the whole study period
2.Coronary heart disease
3.Previously known or treated cardiac arrhythmia of any type
4.Myocardial infarction or stroke within 12 months before study enrolment
5.A body weight exceeding Body Mass Index of 32 kgm-2
6.Patient has a history of or current abuse or dependence on any substance with abuse potential according to DSM-IV-TRTM. This includes alcohol, hypnotics, and drugs of abuse, but excludes nicotine dependence. A patient who fulfils DSM-IV-TRTM criteria for sustained full remission can be included if he/she, in the investigator’s opinion, is not at risk for drug dependence or abuse.
7.Patient has any of the following conditions:
a.restless leg syndrome
b.severe or acute respiratory failure
c.myasthenia gravis
d.proneness to muscle spasm or epileptic seizure.
8.Use of disallowed recent/concomitant therapy:
a.An investigational drug within 3 months prior to screening visit.
b.Use of any psychoactive or hypnotic drug (including herbal remedies) or benzodiazepines within 1 week prior to screening visit.
c.Depot antipsychotics within 6 months prior to screening.
d.Use of antihistamines with sedative properties within 2 weeks prior to screening visit.
e.Use of any drug containing opiate or opiate derivatives.
f.Use of antiepileptics within 14 days prior to screen visit.
g.Serotonin reuptake inhibitors
h.Mirtazepin
i.Flurazepam or diazepam within 2 weeks prior to screening visit.
j.Weight reducing drugs.
k.Hormone replacement therapy is allowed when given at least under the last three months with constant dosage

9.The patient consumes on average more than 14 units (females) or more than 21 units (males) of alcohol per week on a regular basis (glasses of wine/beer and its equivalent).
10.History of severe drug allergy or hypersensitivity, or known hypersensitivity to donepezil.
11.Patient has a known positive HIV test or chronic hepatitis B/C.
12.Diseases/medication, which, judged by the investigator, could interfere with the assessments of safety, tolerability or efficacy.
13.Unstable serious illness and/or serious sequelae thereof, including liver or renal insufficiency, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbances. (If there is history of such disease but the condition has been stable for at least one year and is judged by the investigator not to lead to an unsafe inclusion and not to interfere with the patient’s participation in the study, the patient may be included).
14.The patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any other reasons.
15.Laboratory values at screening outside the normal ranges, considered by the investigator to be clinically significant. If urine creatinine is out of range, impaired renal function has to be considered.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified