To assess the efficacy and tolerability of HUTS with different angles, leading to optimal implementation strategies of HUTS to alleviate the impact of orthostatic hypotension and supine hypertension in PD
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Overnight blood pressure (BP) from 24-hour ABPM between patients and controls
Secondary outcome
Secondary endpoints include: daily supine blood pressure, orthostatic blood
pressure, orthostatic tolerance (complaints of orthostatic hypotension),
nocturia, PD motor- and non-motor symptoms, physical activity during the day,
falls and subjective comfort of HUTS.
Background summary
Othostatic dysfunction is common, disabling and often underrecognized in
Parkinson*s disease (PD). Orthostatic hypotension affects up to a third of
patients with PD. About half of them also exhibit supine hypertension. In
current clinical practice, both are undertreated. Importantly, the common
co-occurrence of orthostatic hypotension and supine hypertension complicates
pharmacological treatment, as improvement of one can be accomplished only at
the expense of the other. Sleeping in a head-up tilt position (HUTS) is the
only known intervention that could improve both. The concept of HUTS is based
on several small-scale observational studies and expert opinion. HUTS has been
proposed as a first-choice treatment for orthostatic hypotension for over three
decades. However, it is often not advised to patients in daily practice because
of a lack of evidence on its* effectiveness, tolerability and on how to
implement it. Moreover, when it is recommended, most physicians prescribe low
tilt angles which presumably have no effect on symptoms.
Study objective
To assess the efficacy and tolerability of HUTS with different angles, leading
to optimal implementation strategies of HUTS to alleviate the impact of
orthostatic hypotension and supine hypertension in PD
Study design
Double-blind multicenter placebo controlled intervention study (phase II)
Intervention
All participants will sleep in whole-body head-up tilt (HUTS) in three angles
for two weeks (6°, 12° and 18° for the intervention group; 1°, 6° and 12° for
control groups). The 1° condition in the control group is considered the
control intervention. and each angle is preceded by a week ofof the HUTS
sleeping position is The intervention period is preceded by a week of
horizontal sleeping used for baseline measurements in both groups. The
materials used to tilt the bed are personalized to the specific situation of
the patient (i.e. double or single matrass) and the patient is guided by a home
visit and (bi)weekly video visits by the researcher. When necesary, additional
home visits are scheduled. When an increased angle is no longer tolerable, the
patient is asked to return to the former angle according to the study
protocol..
Study burden and risks
The burden of participating in this study consists of 2 in-clinic visits (at
the start and end of study) and several home-based measurements (during 7 weeks
of participation), in addition to the intervention itself. The in-clinic
meetings involve questionnaires, a tilt-table-test (1st visit only), a standing
blood pressure test (1st visit only), a timed up and go test and questions on
barriers and facilitators of HUTS (last visit only). Every in-clinic visit will
take approximately 120 minutes. During the study period of 7 weeks, several
home-based blood pressure measurements will be done: 1) 24-hour ABPM 4 times,
2) standing blood pressure test 4 times (guided), 3) daily supine blood
pressure in the morning. In addition, participants are asked to wear an
activity tracker continuously for 7 weeks and complete a questionnaire every
week. Finally, will ask participants to use an urinal during the nights and
note the total urine production. The procedures alltogether can be a burden for
patients, which we will try to minimize by giving good and clear instructions
and by keeping in close contact with the participants throughout the study.
Possible risks involve a skin rash due to the straps of the blood pressure
device or activity tracker. In case this occurs participants are asked to
immediately remove the strap. Risks of falling due to light-headedness during
the blood pressure standing test will be minimized by guidance (video call) and
participants are advised to sit down in case symptoms occur. Finally, the
participants may experience difficulties getting out of bed due to increased
height of the bed when sleeping in head-up tilt. To prevent falls we will
provide a firm raised platform beside the bed and we will inform participants
extensively about this potential risk and provide advices to minimize it. .
Reinier Postlaan 4
Nijmegen 6524 GC
NL
Reinier Postlaan 4
Nijmegen 6524 GC
NL
Listed location countries
Age
Inclusion criteria
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.
Exclusion criteria
Cognitively unable to follow instructions or to fill out questionnaires as
judged by the researcher
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80610.091.22 |