Improving Sleep In Midlife Women
ConditionPoor Sleep Quality
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-65
SponsorThe University of Texas Medical Branch, Galveston
About this trial
This study purpose of this study to see how consuming pistachios and completing a health intervention session a study therapist may improve sleep health in midlife women with poor sleep. Participants in this study will be asked to consume a study snack for about one month, complete a health education session with a study therapist and record information about their sleep. At baseline and after the intervention we will collect information about sleep, alertness, body composition, and blood lipids.
Eligibility criteria
Qualifiers
All races and ethnic backgrounds
Between the ages of 45-65 years old
Women who meet STRAW staging criteria for late peri-menopause (STRAW score of -1) defined as interval of amenorrhea of 60 days OR meet STRAW staging criteria for early post-menopause (STRAW score of +1a, +1b or +1c) defined as >12 months since last menstrual period
History of poor sleep quality (Pittsburgh Sleep Quality Index score > 5)
Disqualifiers
Pregnancy or lactation
including, systemic steroids, anabolic steroids, growth hormone, immunosuppressants, psychotherapy)
recent (within the last 3 months) change in antidepressant medication useage or dosage
Untreated comorbid sleep disorders that are no known to be responsive to the behavioral interventions: These sleep disorders include but are not limited to narcolepsy, circadian rhythm disorder/shift work, restless leg syndrome, periodic leg movement disorder, obstructive sleep apnea.
Trial design
Treatments tested in this trial
- HealthyHabits1
- HealthyHabits2
- Snack 2
- Snack 1
Treatment groups
72 Participants
are divided into 3 treatment groupsSponsors and collaborators
The University of Texas Medical Branch, Galveston
Lead sponsor
American Pistachio Growers
Collaborator
Source ClinicalTrials.gov