Parkinson Disease, Parkinsonism
Conditions
Keywords
Parkinson's disease, Orthostatic hypotension, Supine hypertension, Autonomic dysfunction
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.
Interventions
OTHERHead-up tilt sleeping
Whole-body head-up tilt sleeping (HUTS) will be carried out in three different angles, each for the duration of two weeks. Prior to the first angle the participant will sleep in a horizontal position for 1 week. The different angles will be installed using a wedge between the mattress and bed frame.
Sponsors
Leiden University Medical Center
Michael J. Fox Foundation for Parkinson's Research
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Both the investigator and the participants are blinded to treatment allocation.
Intervention model description
Participants are divided into two groups, the intervention and control (delayed intervention) group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average overnight supine blood pressure | Measured four times: in week 1, 3, 5 and 7 | Average overnight supine blood pressure (mmHg) from the 24h ambulatory blood pressure measurement (ABPM) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Orthostatic blood pressure | 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) | Standing orthostatic blood pressure test (mmHg). Measured in clinic and home-based guided by a researcher via video call. |
| Daily supine blood pressure | Daily in week 1 up to and including week 7 | Supine blood pressure (mmHg) measured every morning directly after awakening before getting out of bed |
| 24h ABPM parameters | In week 1, 3, 5 and 7 | 24h ABPM parameters blood pressure variability (mmHg), nocturnal blood pressure dipping (mmHg) and average daytime blood pressure (mmHg). Each of these measures will be derived from the 24 hour blood pressure measurements, and reported separately. |
| Orthostatic tolerance | Week 1, 3, 5 and 7 | Self-reported burden of symptoms of orthostatic hypotension (Orthostatic hypotension questionnaire (OHQ)). The score ranges from 0 to 100, with a higher number meaning worse symptoms of orthostatic hypotension. |
| Nocturia | Week 1, 3, 5 and 7 | Self-reported frequency of daytime and night time urination and impact on quality of life (International Consultation on Incontinence Questionnaire Nocturia Module (ICIQ-N)) |
| Subjective comfort of HUTS (head up tilted sleeping) | Week 1, 3, 5 and 7 | Self-reported tolerability of the head up tilted sleeping at different angles including questions about sleep duration, sleep quality and comfort, and feeling rested in the morning. |
| Falls | Week 1, 3, 5 and 7 | Self-reported falls and in case of a fall additional questions about the time and circumstances |
| Overnight change in body weight | Daily in week 1 up to and including week 7 | Weight (kg) difference between the evening and the morning, both measured after micturition |
| Nighttime urine production | Week 1, 3, 5 and 7 | Urine volume measured in a urinal (ml) |
| Barriers and facilitators of the intervention | Immediately post-intervention (day after week 7, T1) | Structured interview |
Other
| Measure | Time frame | Description |
|---|---|---|
| Symptoms of Parkinson's disease | Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1) | Movement disorders society unified disease rating scale (MDS-UPDRS). Scores range from 0 to 199, with a higher score indicating a more severe impairment related to Parkinson's disease. |
| Quality of sleep | Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1) | Pittsburgh Sleep Quality Index (PSQI). Score ranges from 0 to 21, with 21 indicating a worse sleep quality. |
| Subjective level of physical activity | Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1) | Longitudinal Aging Study Amsterdam (LASA) Physical Activity Questionnaire (LAPAQ). Score corresponds to time spend doing physical activities. A higher score indicates a more active last two weeks. |
| Cardiovascular autonomic symptoms | Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1) | Selected cardiovascular questions from the Scales for Outcomes in Parkinson's Disease - Autonomic Dysfunction (SCOPA-AUT). Scored 0 to 9, a worse score means more symptoms of orthostatic hypotension. |
| Experienced quality of life | Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1) | Quality of life questionnaire: the Parkinson's disease questionnaire (PDQ-39). Scores range from 0 to 100, with a higher score indicating a worse quality of life. |
| Experienced anxiety and depression | Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1) | Quality of life questionnaire: the hospital anxiety and depression scale (HADS). Scores range from 0 to 21 for depression and anxiety, a score between 0-7 means no anxiety or depression, 8-14 possibility of an anxiety or depressive disorder and 15-21 likely a depressive or anxiety disorder. |
| Mental health | Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1) | Quality of life questionnaire: the Mental Health Continuum-Short Form (MHC-SF). Scores range from 0 to 70, with a higher score meaning a better emotional wellbeing. |
| Timed up and go test (TUG) | Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1) | Measurement of the time that the participant takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees |
| Fear of falling | Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1) | Falls Efficacy Scale (FES). Scores ranges from 16 to 67, with a higher score meaning a worse fear of falling. |
Countries
Netherlands
Outcome results
None listed