Poor Sleep Quality study: HealthyHabits1 vs HealthyHabits2
Official title Improving Sleep In Midlife Women
ClinicalTrials.gov ID: NCT07337915
What this study is testing
- What it's testing
- The study aims to find out if eating pistachios and meeting with a health therapist can improve sleep quality in women going through midlife.
- Who it's for
- The study is looking for midlife women who currently have poor sleep quality.
- What's involved
- Participants will eat a specific snack containing pistachios for about one month, attend a health education session with a therapist, and keep a record of their sleep. They will also have tests to check sleep, alertness, body composition, and blood fats at the start and end of the study.
- Time commitment
- The study lasts about one month and requires visits at the beginning and end to complete tests and record sleep data.
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
- 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...
- Recent (within past 3 years) treated cancer other than basal cell carcinoma
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
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Galveston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.