Head-up Tilt Sleeping to Alleviate Orthostatic Hypotension, Supine Hypertension and Nocturia in Parkinson's Disease

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05551377
• Other study ID #: NL.80610.091.22
• Secondary ID: MJFF-020200
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2023
• Est. completion date: June 2024

Study information

• Verified date: November 2023
• Source: Radboud University Medical Center
• Contact: Amber van der Stam, MSc
• Phone: +31 6 29677748
• Email: Amber.vanderStam[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Hypertension
• Hypotension
• Hypotension, Orthostatic
• Nocturia
• Parkinson Disease
• Parkinsonian Disorders
• Parkinsonism

Intervention

Other:
• Head-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.

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden	Zuid Holland
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (3)

Lead Sponsor	Collaborator
Radboud University Medical Center	Leiden University Medical Center, Michael J. Fox Foundation for Parkinson's Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Timed up and go test (TUG)	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	Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Other	Symptoms of Parkinson's disease	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.	Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Other	Quality of sleep	Pittsburgh Sleep Quality Index (PSQI). Score ranges from 0 to 21, with 21 indicating a worse sleep quality.	Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Other	Fear of falling	Falls Efficacy Scale (FES). Scores ranges from 16 to 67, with a higher score meaning a worse fear of falling.	Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Other	Subjective level of physical activity	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.	Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Other	Cardiovascular autonomic symptoms	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.	Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Other	Experienced quality of life	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.	Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Other	Experienced anxiety and depression	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.	Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Other	Mental health	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.	Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Primary	Average overnight supine blood pressure	Average overnight supine blood pressure (mmHg) from the 24h ambulatory blood pressure measurement (ABPM)	Measured four times: in week 1, 3, 5 and 7
Secondary	Daily supine blood pressure	Supine blood pressure (mmHg) measured every morning directly after awakening before getting out of bed	Daily in week 1 up to and including week 7
Secondary	Orthostatic blood pressure	Standing orthostatic blood pressure test (mmHg). Measured in clinic and home-based guided by a researcher via video call.	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)
Secondary	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.	In week 1, 3, 5 and 7
Secondary	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.	Week 1, 3, 5 and 7
Secondary	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))	Week 1, 3, 5 and 7
Secondary	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.	Week 1, 3, 5 and 7
Secondary	Falls	Self-reported falls and in case of a fall additional questions about the time and circumstances	Week 1, 3, 5 and 7
Secondary	Overnight change in body weight	Weight (kg) difference between the evening and the morning, both measured after micturition	Daily in week 1 up to and including week 7
Secondary	Nighttime urine production	Urine volume measured in a urinal (ml)	Week 1, 3, 5 and 7
Secondary	Barriers and facilitators of the intervention	Structured interview	Immediately post-intervention (day after week 7, T1)