The HEADS-Up Trial: Sleeping in a head-up tilt position to treat orthostatic hypotension, supine hypertension and nocturia in Parkinson's disease
- Conditions
- ParkinsonParkinson's disease10028037
- Registration Number
- NL-OMON51733
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
1. Orthostatic hypotension defined as a systolic BP decrease of >=20 mmHg, or a
diastolic decrease of >=10 mmHg, within 3 min after changing from a supine to
standing position OR mean standing BP of <=75 mmHg (marker for symptomatic
orthostatic hypotension). In patients with supine hypertension, a decrease in
systolic BP of >= 30 mmHg is required.
2. Orthostatic intolerance: direct complants (dizziness, tunnel- or blurry
vision etc.) and/or inirect signs (falls or freezing episodes that relate to
postual challenge)
3. Supine hypertension defined as a systolic BP of >=140 mmHg, and/or diastolic
of >=90 mmHg, after 5 min of supine rest.
4. Idiopathic PD.
5. Ability to walk (with or without a walking aid).
6. Stable medication regimens for orthostatic hypotension and supine
hypertension.
Cognitively unable to follow instructions or to fill out questionnaires as
judged by the researcher
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Overnight blood pressure (BP) from 24-hour ABPM between patients and controls </p><br>
- Secondary Outcome Measures
Name Time Method <p> Secondary endpoints include: daily supine blood pressure, orthostatic blood<br /><br>pressure, orthostatic tolerance (complaints of orthostatic hypotension),<br /><br>nocturia, PD motor- and non-motor symptoms, physical activity during the day,<br /><br>falls and subjective comfort of HUTS.</p><br>