Nocturia study: MI vs BBTI+MI
Official title Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
ClinicalTrials.gov ID: NCT07760779
What this study is testing
- What it's testing
- This study is testing whether changing sleep habits or practicing mindfulness helps. It looks at how well these methods reduce nighttime trips to the bathroom.
- Who it's for
- You may be able to join if you are a woman over 65 who wakes up at night to pee.
- What's involved
- You would be picked by chance, like a coin toss, to get one of four groups. You would keep a diary of your bathroom trips and use a home sleep monitor.
- Time commitment
- The study lasts about six months with check-ins at the end of treatment and later.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older, women only
You may be able to join if
- Female
- Age \> or =65 years
- Nocturia ≥2/night
- Poor sleep (Insomnia Severity Index ≥8)
- MoCA (including trail making) \>26
You likely can't join if
- Conditions that affect bladder function: Multiple sclerosis, Alzheimer's disease, spinal cord injury, urethral obstruction, urinary retention...
- cardiac or respiratory disease that limits daily function
- Unstable or acute medical condition: \- Any acute medical condition that requires immediate treatment such that it would interfere with the study...
- Untreated, current, severe psychiatric condition (assessed during Visit 1a- medical history)
- Post void residual ≥ 200ml- assessed during baseline visit
- Currently diagnosed and/or untreated obstructive sleep apnea, untreated restless leg syndrome, untreated parasomnia
See the full eligibility criteria
- Female
- Age \> or =65 years
- Nocturia ≥2/night
- Poor sleep (Insomnia Severity Index ≥8)
- MoCA (including trail making) \>26
- Conditions that affect bladder function: Multiple sclerosis, Alzheimer's disease, spinal cord injury, urethral obstruction, urinary retention, interstitial cystitis, bladder cancer, radiation to the pelvic area, bladder...
- cardiac or respiratory disease that limits daily function
- Unstable or acute medical condition: \- Any acute medical condition that requires immediate treatment such that it would interfere with the study protocol
- Untreated, current, severe psychiatric condition (assessed during Visit 1a- medical history)
- Post void residual ≥ 200ml- assessed during baseline visit
- Currently diagnosed and/or untreated obstructive sleep apnea, untreated restless leg syndrome, untreated parasomnia
- Untreated or poorly controlled fluid overload conditions like CHF, diabetes
The study team makes the final eligibility decision.
Where it is enrolling
- Pittsburgh, Pennsylvania, 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, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Pittsburgh, Pennsylvania, 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.