PrehypertensionNCT03255746
HELP-HY: Health Education and sLeep Program in HYpertension
A study testing Sleep Enhancement and Health Education in people with Prehypertension and Hypertension, run by Mayo Clinic at 1 site in United States.
Trial summary
Hypertension is the major risk factor for cardiovascular and cerebrovascular diseases worldwide. The escalating prevalence of inadequate sleep now parallels that of hypertension. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Prehypertension, Hypertension
- What is being tested?
- Sleep Enhancement and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2018to 20 Mar 2025
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18 to 65 (inclusive)
- Gender: both males and females
- Body mass index (BMI): 18.5-34.9 kg/m2
- Habitual sleep duration <7 hours and voluntary prolongation of sleep when circumstances allow (as indicated by napping and/or >45 min catch-up sleep during weekends or holidays)
- Presence of prehypertension (office systolic BP (SBP) 120-139 mmHg and/or diastolic BP (DBP) 80-89 mmHg) , Stage 1 hypertension (office SBP 140-159 mmHg and/or DBP 90-99 mmHg ) , or currently taking antihypertensive medications
- Either on no prescription medications (other than oral contraceptive pills, or intrauterine devices) or on stable medical regimen for at least 1 month, if taking prescription medications for chronic conditions
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- Not pregnant or breast feeding and not intending to become pregnant or breast feed
- Not a current smoker or tobacco user
- Ability to provide written informed consent.
Who cannot join
- Vulnerable study populations will be excluded
- Pregnancy
- Smoking
- Shift-work
- Travel across >2 time zones in the previous month
- Presence of overt cardiovascular diseases, diabetes, chronic kidney disease, cancer, sleep/circadian disorders, psychiatric disorders
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- If taking prescription medications for chronic conditions, change in therapy (type, frequency and/or dosage) over the previous month
- Sleep aids
- Habitual sleep duration ≥7 hours
- Excessive alcohol (>14 drinks/week in men and >7 drinks/week in women) and/or excessive caffeine intake (>400 mg)
- Currently on a diet and/or actively trying to lose weight
- History of drowsing driving
- Severe daytime sleepiness (score >15 at the Epworth Sleepiness Scale)
- Current or previous (during the past 2 months) participation in other research studies at the discretion of study personnel
- Blood/plasma donation during the past 2 months
- Unwillingness or inability to adjust sleep schedule
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Hypertension is the major risk factor for cardiovascular and cerebrovascular diseases worldwide. The escalating prevalence of inadequate sleep now parallels that of hypertension. Observational and experimental evidence favoring a causal relation between insufficient sleep and hypertension are particularly compelling - sleeping 6 hours or less per night is associated with a 20-32% higher probability of incident hypertension. Since sleep curtailment is largely voluntary, sleep deficiency may be corrected and the detrimental health consequences potentially reversed.
In this study the investigators aim to investigate the effects of 8 weeks of sleep enhancement/extension vs health education in prehypertensive and stage 1 hypertensive subjects who report habitual short sleep (≤6.5 hours/night).
- Conditions
- Prehypertension, Hypertension
- Being tested
- Sleep Enhancement, Health Education
- Medical subject headings
- Prehypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep EnhancementBehavioural
This regimen combines education and behavioral skills to enable prolonging sleep in chronically sleep deprived subjects so as to better meet participant's sleep needs. This intervention emphasizes plain language communication of cognitive behavioral therapy strategies for initiating and maintaining health behavior change, primarily through using brief action plans (time-limited, personally relevant, behavioral goal setting with confidence), and collaborative problem-solving. Coaching will be provided to modify daily routines and adhere to sleep hygiene practices to allow for extended time in bed.
Health EducationBehavioural
This is a placebo/attention control condition. Participants will receive health education based on NIH information. Number, duration, and frequency of sessions will be identical to those administered to the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Enhancement | Experimental | Not described Receives: Behavioral: Sleep Enhancement |
| Health Education | Placebo comparator | Not described Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in 48-hour mean arterial pressure
changes in ambulatory measure of blood pressure
Measured: 8 weeks
Secondary outcomes (10)
changes in 48-hour heart rate
changes in 24-hour heart rate
Measured: 8 weeks
changes in baroreflex sensitivity
changes in baroreflex sensitivity
Measured: 8 weeks
changes in endothelial function
changes in endothelial function
Measured: 8 weeks
changes in renin
changes in renin
Measured: 8 weeks
changes in angiotensin peptides
changes in angiotensin peptides
Measured: 8 weeks
changes in aldosterone
changes in aldosterone
Measured: 8 weeks
changes in insulin sensitivity
changes in insulin sensitivity
Measured: 8 weeks
changes in cortisol
changes in cortisol
Measured: 8 weeks
changes in body fat
changes in body fat
Measured: 8 weeks
changes in catecholamines
changes in catecholamines
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start19 Apr 2018
- Primary completion20 Mar 2025
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrehypertensionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Virend Somers, MD, PhD, Mayo Clinic
- Investigators
- Virend Somers, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255746
- Sponsor's protocol ID
- 17-004044
- Other IDs
- R01HL134808
- Status last verified
- Jul 2026
- First submitted
- 8 Aug 2017
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HELP-HY: Health Education and sLeep Program in HYpertension
- ClinicalTrials.gov ID
- NCT03255746
- Acronym / sponsor ID
- 17-004044
- Conditions
- Prehypertension, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 21 Aug 2017 (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.
Hypertension is the major risk factor for cardiovascular and cerebrovascular diseases worldwide. The escalating prevalence of inadequate sleep now parallels that of hypertension. Observational and experimental evidence favoring a causal relation between insufficient sleep and hypertension are particularly compelling - sleeping 6 hours or less per night is associated with a 20-32% higher probability of incident hypertension. Since sleep curtailment is largely voluntary, sleep deficiency may be corrected and the detrimental health consequences potentially reversed.
In this study the investigators aim to investigate the effects of 8 weeks of sleep enhancement/extension vs health education in prehypertensive and stage 1 hypertensive subjects who report habitual short sleep (≤6.5 hours/night).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Enhancement | Experimental | Behavioral: Sleep Enhancement |
| Health Education | Placebo comparator | Behavioral: Health Education |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: 18 to 65 (inclusive)
- Gender: both males and females
- Body mass index (BMI): 18.5-34.9 kg/m2
- Habitual sleep duration <7 hours and voluntary prolongation of sleep when circumstances allow (as indicated by napping and/or >45 min catch-up sleep during weekends or holidays)
- Presence of prehypertension (office systolic BP (SBP) 120-139 mmHg and/or diastolic BP (DBP) 80-89 mmHg) , Stage 1 hypertension (office SBP 140-159 mmHg and/or DBP 90-99 mmHg ) , or currently taking antihypertensive medications
Key exclusion criteria (16 listed)
- Vulnerable study populations will be excluded
- Pregnancy
- Smoking
- Shift-work
- Travel across >2 time zones in the previous month
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 |
|---|---|---|
| Sleep EnhancementThis regimen combines education and behavioral skills to enable prolonging sleep in chronically sleep deprived subjects so as to better meet participant's sleep needs. This intervention emphasizes plain language communication of cognitive behavioral therapy strategies for initiating and maintaining health behavior change, primarily through using brief action plans (time-limited, personally relevant, behavioral goal setting with confidence), and collaborative problem-solving. Coaching will be provided to modify daily routines and adhere to sleep hygiene practices to allow for extended time in bed. | Behavioural | Sleep Enhancement |
| Health EducationThis is a placebo/attention control condition. Participants will receive health education based on NIH information. Number, duration, and frequency of sessions will be identical to those administered to the intervention group. | Behavioural | Health Education |
Primary outcome
change in 48-hour mean arterial pressure
Time frame: 8 weeks
changes in ambulatory measure of blood pressure
10 secondary outcomes
changes in 48-hour heart rate
Time frame: 8 weeks
changes in baroreflex sensitivity
Time frame: 8 weeks
changes in endothelial function
Time frame: 8 weeks
changes in renin
Time frame: 8 weeks
changes in angiotensin peptides
Time frame: 8 weeks
changes in aldosterone
Time frame: 8 weeks
changes in insulin sensitivity
Time frame: 8 weeks
changes in cortisol
Time frame: 8 weeks
changes in body fat
Time frame: 8 weeks
changes in catecholamines
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Virend Somers, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Enhancement and Health Education in people with Prehypertension and Hypertension, run by Mayo Clinic at 1 site in United States.
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 9 inclusion and 16 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: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change in 48-hour mean arterial pressure (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2026.