Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).

NCT ID: NCT02688465

Last Updated: 2018-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-05

Study Completion Date

2017-07-31

Brief Summary

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Parkinson's disease is not only a pathology of movements. There are many non-motor symptoms that complicate and impair patients' quality of life. Among those disorders are sleep disorders.

Insomnia is the most frequent symptom. Most patients report 2-5 awakenings per night and long periods of awakening which occupy 30 to 40% of their night.

Apomorphine is a dopamine agonist that may be administered with a pump . The objective of the study is to assess changes in the quality of sleep in Parkinson's disease patients treated with an apomorphine pump.

Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Apomorphine pump

Group Type EXPERIMENTAL

Apomorphine

Intervention Type DRUG

Interventions

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Apomorphine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Parkinson's disease patients for whom a treatment with an apomorphine pump is indicated

Exclusion Criteria

* atypical parkinsonian syndrome
* cognitive impairment
* pregnancy
* breast feeding
* patient under a legal protection procedure
* patient denying to participate to the study
* lack of affiliation to a social security system
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondation ophtalmique Adolphe de Rothschild

Paris, , France

Site Status

Countries

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France

Other Identifiers

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CHH_2016_01

Identifier Type: -

Identifier Source: org_study_id

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