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Targeted Sleep Intervention for Sleep

N/A
Waitlist Available
Led By Christopher DeSouza, PhD
Research Sponsored by University of Colorado, Boulder
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
sedentary as determined from the Stanford Physical Activity Questionnaire (<35 kcal/wk) and will not have engaged in any program of regular physical activity for at least 6 months prior to the study.
Subjects that have a pre-existing diagnosis of obstructive sleep apnea, or are determined to have obstructive sleep apnea based on their sleep disorders screening visit will be allowed in the study, but will not take part in the sleep intervention/post sleep intervention visits.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up t-pa release will be measured during phase 2 at the participants visit 9 which is ~13 weeks from their respective start date.
Awards & highlights

Study Summary

This trial will test whether chronic insufficient sleep is associated with diminished function of the endothelium (the layer of cells lining blood vessels). The investigators hypothesize that improving sleep duration and quality will increase both endothelium-dependent nitric oxide-mediated vasodilation and endothelial tissue-type plasminogen activator release in adults with elevated blood pressure.

Eligible Conditions
  • Sleep
  • High Blood Pressure

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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They have been determined to be sedentary from the Stanford Physical Activity Questionnaire (<35 kcal/wk) and have not engaged in any program of regular physical activity for at least 6 months prior to the study.
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Subjects that have a pre-existing diagnosis of obstructive sleep apnea, or are determined to have obstructive sleep apnea based on their sleep disorders screening visit, will be allowed to participate in the study but will not take part in the sleep intervention/post sleep intervention visits.
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This study will include men and women of all different races and ethnic backgrounds between the ages of 45 and 65.
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Most women will experience menopause at some point, even if they're not taking hormone replacement therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~t-pa release will be measured during phase 2 at the participants visit 9 which is ~13 weeks from their respective start date.
This trial's timeline: 3 weeks for screening, Varies for treatment, and t-pa release will be measured during phase 2 at the participants visit 9 which is ~13 weeks from their respective start date. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1: Diastolic Blood Pressure (DBP)
Phase 1: Endothelial t-PA Release in response to Bradykinin (BDK)
Phase 1: FBF response to ACh+L-NMMA
+11 more
Secondary outcome measures
Phase 1: Epworth Sleepiness Scale
Phase 1: Insomnia Severity Index
Phase 1: Pittsburgh Sleep Quality Index (PSQI)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Phase 2Experimental Treatment1 Intervention
Phase II is an intervention study to determine the effects of individualized targeted sleep interventions that increase sleep duration and improve sleep quality on endothelial vasodilator and fibrinolytic function in adults with elevated blood pressure who habitually sleep less than 6.5 hr/night (Specific Aims 3).
Group II: Phase 1Active Control1 Intervention
Phase I is a cross-sectional study to compare endothelial vasodilator and fibrinolytic function in adults with elevated blood pressure who habitually sleep more than 7 hours/night (normal sleep) and those who habitually sleep less than 6.5 hr/night (short sleep)

Find a Location

Who is running the clinical trial?

University of Colorado, BoulderLead Sponsor
119 Previous Clinical Trials
29,152 Total Patients Enrolled
3 Trials studying Sleep
593 Patients Enrolled for Sleep
Christopher DeSouza, PhDPrincipal InvestigatorUniversity of Colorado, Denver
1 Previous Clinical Trials
88 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
~13 spots leftby Mar 2025