Clinical trial NCT05551377: Head-up Tilt Sleeping to Alleviate Orthostatic Hypotension, Supine Hypertension and Nocturia in Parkinson's Disease
Official title: The Heads-Up Trial: Sleeping in a Head-Up Tilt Position to Alleviate Orthostatic Hypotension, Supine Hypertension and Nocturia in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Parkinsonism
Keywords: Parkinson's disease
Orthostatic hypotension
Supine hypertension
Autonomic dysfunction
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Leiden University Medical Center
name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2022-09-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are divided into two groups, the intervention and control (delayed intervention) group.
Primary purpose: TREATMENT

Brief summary: Autonomic dysfunction is common and often underrecognized in Parkinson's disease (PD). Orthostatic hypotension (OH) affects up to a third of PD patients and often coincides with supine hypertension. This co-occurrence complicates pharmacological treatment as treatment of one can negatively affect the other. Head-up tilt sleeping (HUTS) could improve both. This phase II randomized controlled trial (RCT) aims to investigate the efficacy and tolerability of this understudied intervention, leading to optimal implementation strategies.

Detailed description: Autonomic dysfunction is common and often underrecognized in Parkinson's disease (PD). Orthostatic hypotension (OH) affects up to a third of PD patients and about half of them also exhibit supine hypertension. In current clinical practice both are undertreated. The common co-occurrence of OH and supine hypertension complicates pharmacological treatment as improvement of one can be accomplished only at the expense of the other. Head-up tilt sleeping (HUTS) is the only intervention known that could improve both. The concept of HUTS is based on several small-scale observational studies and expert opinion. Although HUTS has been proposed as an effective and even first choice non-pharmacological treatment for OH for over three decades, it is often not advised to patients because of lack of evidence on its effectiveness and on how to implement it. The Heads-Up trial is a multicenter home-based double-blind phase II RCT. The study aims to investigate the efficacy and tolerability of HUTS, leading to optimal implementation strategies of HUTS to treat orthostatic hypotension and supine hypertension.

Eligibility criteria: Inclusion Criteria:

* 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;
* Orthostatic intolerance: direct complaints (dizziness, blurry vision, etc.) and/or indirect signs (falls or freezing episodes that relate to postural challenge);
* Supine hypertension defined as a systolic BP of ≥140 mmHg, and/or diastolic of ≥90 mmHg, after 5 min of supine rest;
* Idiopathic PD or parkinsonism (multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, vascular parkinsonism and Lewy body dementia);
* Ability to walk (with or without a walking aid), as subjectively determined by the researcher;
* Stable medication regimens for orthostatic hypotension and supine hypertension during the trial;

Exclusion Criteria:

* Inability to follow instructions and complete questionnaires, as assessed by the researcher;

Primary outcomes:
measure: Average overnight supine blood pressure
timeFrame: Measured four times: in week 1, 3, 5 and 7
Secondary outcomes:
measure: Daily supine blood pressure
timeFrame: Daily in week 1 up to and including week 7
measure: Orthostatic blood pressure
timeFrame: Measured six times: in-clinic (T0; pre-intervention), in week 1, 3, 5 and 7, and in-clinic on the day after week 7 ends (T1; post-intervention)
measure: 24h ABPM parameters
timeFrame: In week 1, 3, 5 and 7
measure: Orthostatic tolerance
timeFrame: Week 1, 3, 5 and 7
measure: Nocturia
timeFrame: Week 1, 3, 5 and 7
measure: Subjective comfort of HUTS (head up tilted sleeping)
timeFrame: Week 1, 3, 5 and 7
measure: Falls
timeFrame: Week 1, 3, 5 and 7
measure: Overnight change in body weight
timeFrame: Daily in week 1 up to and including week 7
measure: Nighttime urine production
timeFrame: Week 1, 3, 5 and 7
measure: Barriers and facilitators of the intervention
timeFrame: Immediately post-intervention (day after week 7, T1)
Other outcomes:
measure: Timed up and go test (TUG)
timeFrame: Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
measure: Symptoms of Parkinson's disease
timeFrame: Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
measure: Quality of sleep
timeFrame: Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
measure: Fear of falling
timeFrame: Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
measure: Subjective level of physical activity
timeFrame: Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
measure: Cardiovascular autonomic symptoms
timeFrame: Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
measure: Experienced quality of life
timeFrame: Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
measure: Experienced anxiety and depression
timeFrame: Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
measure: Mental health
timeFrame: Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Zuid Holland
Study officials:
affiliation: Leiden University Medical Center
name: Roland D Thijs, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: