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New treatment option for Poor Sleep Quality
Official title Improving Sleep In Midlife Women
ClinicalTrials.gov ID: NCT07337915
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 65, women only
You may be able to join if
- 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...
- History of poor sleep quality (Pittsburgh Sleep Quality Index score \> 5)
- Able and willing to provide informed consent
You likely can't join if
- Pregnancy or lactation
- Recent (within the last 3 months) or current use of any prescription or over the counter medications that may impact sleep quality:
- 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...
- Evidence of recent severe mental health disorders (e.g., suicide attempt or psychiatric hospitalization in past 3 years) that would, in the opinion...
See the full eligibility criteria
- 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)...
- History of poor sleep quality (Pittsburgh Sleep Quality Index score \> 5)
- Able and willing to provide informed consent
- Access to an electronic device with teleconferencing capabilities (Teams, etc)
- Willing to consume study intervention
- Fluent (able to read and write) in English
- Pregnancy or lactation
- Recent (within the last 3 months) or current use of any prescription or over the counter medications that may impact sleep quality:
- 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...
- Evidence of recent severe mental health disorders (e.g., suicide attempt or psychiatric hospitalization in past 3 years) that would, in the opinion of the investigator, affect sleep and/or make it difficult for the...
- Recent (within past 3 years) treated cancer other than basal cell carcinoma
- Current adherence to a weight-loss or weight-gain diet or use of GLP-1 RA medications
- Active or recent (within the past 12 months) alcohol or substance use disorder
- Allergy to study intervention (tree nuts)
- Any other condition or event considered exclusionary by study PI
The study team makes the final eligibility decision.
Where it's taking place
- Galveston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 45 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Galveston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.