Parkinson DiseaseNCT05551377
Head-up Tilt Sleeping to Alleviate Orthostatic Hypotension, Supine Hypertension and Nocturia in Parkinson's Disease
A study testing Head-up tilt sleeping in people with Parkinson Disease and Parkinsonism, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Parkinsonism
- What is being tested?
- Head-up tilt sleeping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesNetherlands
- Study dates
- 18 Jan 2023to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- Inability to follow instructions and complete questionnaires, as assessed by the researcher;
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Leiden University Medical Center
Leiden, South Holland, 2333 ZA
Radboudumc
Nijmegen, Gelderland, 6500 HB
About this study
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
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.
Read the 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.
- Conditions
- Parkinson Disease, Parkinsonism
- Being tested
- Head-up tilt sleeping
- Keywords
- Parkinson's disease, Orthostatic hypotension, Supine hypertension, Autonomic dysfunction
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders, Hypotension, Orthostatic, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head-up tilt sleepingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | At T0, in-clinic inclusion, we will record basic characteristics and several questionnaires, we will also perform a short tilt-table-test and standing blood pressure (BP) test. Intake is followed by one week of horizontal sleeping for baseline home-based BP measurements. Participants in the intervention group will then sleep in a head-up tilt position for two weeks each in angles 6°, 12° and 18°. At the second and final in-clinic meeting, at T1, measurements done at T0 will be repeated, complemented with an assessment of barriers and facilitators of HUTS. During HUTS daily BP measurements will be done, and data will be collected on orthostatic tolerance, nighttime urine production, subjective comfort of HUTS, falls. Receives: Other: Head-up tilt sleeping |
| Delayed intervention group | Other | Follows the same structure as the intervention group, but starts with a HUTS placebo angle of 1° for two weeks, followed by two intervention angles of 6° and 12° for two weeks each. The 1°-angle serves as the control intervention. Receives: Other: Head-up tilt sleeping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average overnight supine blood pressure
Average overnight supine blood pressure (mmHg) from the 24h ambulatory blood pressure measurement (ABPM)
Measured: Measured four times: in week 1, 3, 5 and 7
Secondary outcomes (10)
Daily supine blood pressure
Supine blood pressure (mmHg) measured every morning directly after awakening before getting out of bed
Measured: Daily in week 1 up to and including week 7
Orthostatic blood pressure
Standing orthostatic blood pressure test (mmHg). Measured in clinic and home-based guided by a researcher via video call.
Measured: 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)
24h ABPM parameters
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.
Measured: In week 1, 3, 5 and 7
Orthostatic tolerance
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.
Measured: Week 1, 3, 5 and 7
Nocturia
Self-reported frequency of daytime and night time urination and impact on quality of life (International Consultation on Incontinence Questionnaire Nocturia Module (ICIQ-N))
Measured: Week 1, 3, 5 and 7
Subjective comfort of HUTS (head up tilted sleeping)
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.
Measured: Week 1, 3, 5 and 7
Falls
Self-reported falls and in case of a fall additional questions about the time and circumstances
Measured: Week 1, 3, 5 and 7
Overnight change in body weight
Weight (kg) difference between the evening and the morning, both measured after micturition
Measured: Daily in week 1 up to and including week 7
Nighttime urine production
Urine volume measured in a urinal (ml)
Measured: Week 1, 3, 5 and 7
Barriers and facilitators of the intervention
Structured interview
Measured: Immediately post-intervention (day after week 7, T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start18 Jan 2023
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are divided into two groups, the intervention and control (delayed intervention) group.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center, Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Sponsor
- Investigators
- Roland D Thijs, MD, PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551377
- Sponsor's protocol ID
- NL.80610.091.22
- Other IDs
- MJFF-020200
- Status last verified
- Nov 2023
- First submitted
- 7 Sep 2022
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Relevant and anonymized research data will be shared in the validated research database DANS Easy (Data Archiving and Networked Services). It will also be shared with the funding foundation (MJFF).
Publications
van der Stam AH, de Vries NM, Shmuely S, de Bot ST, Claassen JAHR, Fanciulli A, IntHout J, Kerkhof F, van Rossum IA, Rutten JHW, Smeenk D, Wang Y, Bloem BR, Thijs RD. Tolerability and efficacy of full-body head-up tilt sleeping in Parkinson's disease and multiple system atrophy. NPJ Parkinsons Dis. 2026 May 16;12(1):184. doi: 10.1038/s41531-026-01359-y.
PubMed 42143029van der Stam AH, de Vries NM, Shmuely S, Smeenk D, Rutten JH, van Rossum IA, de Bot ST, Claassen JA, Bloem BR, Thijs RD. Study protocol for the Heads-Up trial: a phase II randomized controlled trial investigating head-up tilt sleeping to alleviate orthostatic intolerance in Parkinson's Disease and parkinsonism. BMC Neurol. 2024 Jan 2;24(1):4. doi: 10.1186/s12883-023-03506-x.
PubMed 38166676
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05551377
- Acronym / sponsor ID
- NL.80610.091.22
- Conditions
- Parkinson Disease, Parkinsonism
- Keywords
- Parkinson's disease, Orthostatic hypotension, Supine hypertension, Autonomic dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Leiden University Medical Center, Michael J. Fox Foundation for Parkinson's Research
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants are divided into two groups, the intervention and control (delayed intervention) group.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Head-up tilt sleepingAt T0, in-clinic inclusion, we will record basic characteristics and several questionnaires, we will also perform a short tilt-table-test and standing blood pressure (BP) test. Intake is followed by one week of horizontal sleeping for baseline home-based BP measurements. Participants in the intervention group will then sleep in a head-up tilt position for two weeks each in angles 6°, 12° and 18°. At the second and final in-clinic meeting, at T1, measurements done at T0 will be repeated, complemented with an assessment of barriers and facilitators of HUTS. During HUTS daily BP measurements will be done, and data will be collected on orthostatic tolerance, nighttime urine production, subjective comfort of HUTS, falls. |
| Delayed intervention group | Other | Other: Head-up tilt sleepingFollows the same structure as the intervention group, but starts with a HUTS placebo angle of 1° for two weeks, followed by two intervention angles of 6° and 12° for two weeks each. The 1°-angle serves as the control intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (1 listed)
- Inability to follow instructions and complete questionnaires, as assessed by the researcher;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Head-up tilt sleepingWhole-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. | Other | Delayed intervention group, Intervention group |
Primary outcome
Average overnight supine blood pressure
Time frame: Measured four times: in week 1, 3, 5 and 7
Average overnight supine blood pressure (mmHg) from the 24h ambulatory blood pressure measurement (ABPM)
10 secondary outcomes
Daily supine blood pressure
Time frame: Daily in week 1 up to and including week 7
Orthostatic blood pressure
Time frame: 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)
24h ABPM parameters
Time frame: In week 1, 3, 5 and 7
Orthostatic tolerance
Time frame: Week 1, 3, 5 and 7
Nocturia
Time frame: Week 1, 3, 5 and 7
Subjective comfort of HUTS (head up tilted sleeping)
Time frame: Week 1, 3, 5 and 7
Falls
Time frame: Week 1, 3, 5 and 7
Overnight change in body weight
Time frame: Daily in week 1 up to and including week 7
Nighttime urine production
Time frame: Week 1, 3, 5 and 7
Barriers and facilitators of the intervention
Time frame: Immediately post-intervention (day after week 7, T1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Derived from this study: PubMed 42143029van der Stam AH, de Vries NM, Shmuely S, de Bot ST, Claassen JAHR, Fanciulli A, IntHout J, Kerkhof F, van Rossum IA, Rutten JHW, Smeenk D, Wang Y, Bloem BR, Thijs RD. Tolerability and efficacy of full-body head-up tilt sleeping in Parkinson's disease and multiple system atrophy. NPJ Parkinsons Dis. 2026 May 16;12(1):184. doi: 10.1038/s41531-026-01359-y.
- Derived from this study: PubMed 38166676van der Stam AH, de Vries NM, Shmuely S, Smeenk D, Rutten JH, van Rossum IA, de Bot ST, Claassen JA, Bloem BR, Thijs RD. Study protocol for the Heads-Up trial: a phase II randomized controlled trial investigating head-up tilt sleeping to alleviate orthostatic intolerance in Parkinson's Disease and parkinsonism. BMC Neurol. 2024 Jan 2;24(1):4. doi: 10.1186/s12883-023-03506-x.
- Individual participant dataSharing planned: Yes. Relevant and anonymized research data will be shared in the validated research database DANS Easy (Data Archiving and Networked Services). It will also be shared with the funding foundation (MJFF).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland D Thijs, MD, PhD principal investigator
Leiden University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Head-up tilt sleeping in people with Parkinson Disease and Parkinsonism, run by Radboud University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average overnight supine blood pressure (time frame: Measured four times: in week 1, 3, 5 and 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05551377, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.