80 Participants NeededMy employer runs this trial

Behavioral Sleep and Mindfulness Therapy for Nocturia

(ANOWSM Trial)

ST
BD
Overseen ByBecky D Clarkson, PhD
Age: 65+
Sex: Female
Trial Phase: Academic
Sponsor: University of Pittsburgh
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to examine and compare the effect of behavioral sleep treatment: BBTI (brief behavioral treatment of insomnia) and brief mindfulness (MI), independently and combined vs control on frequency of nighttime awakenings to void (nocturia) and on nighttime urine production in older women over the age 65 years with nocturia.

To study the effect of these treatments, participants will be randomly assigned to one of the following groups 1) BBTI alone, 2) MI alone, 3) BBTI+MI, or 4) control: sleep information only without any structured sleep or mindfulness therapy.

The study aims to examine the effect of these therapies at end-of-treatment (week 4), as well sustained effects at 3- and 6-months. The main questions the study aims to answer are:

1. do these treatments reduce the frequency of nighttime awakenings to void

2. do these treatments reduce the volume of nighttime urine production

3. do these treatments improve sleep quality

Frequency of nocturia and sleep quality will be assessed via questionnaires and nighttime urine volume using bladder-sleep diaries which is 3-day record participants will complete at home documenting every time they go to the bathroom and volume they voided. In addition, sleep and sleep interruptions will also be assessed using an FDA-cleared home sleep testing device called Zmachine®.

Who Is on the Research Team?

BD

Becky D Clarkson, PhD

Principal Investigator

University of Pittsburgh

ST

Shachi Tyagi, MD, MS

Principal Investigator

University of Pittsburgh

ST

Shachi Tyagi, MD, MS

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for women over age 65 who wake up at night to urinate (nocturia) and have trouble falling asleep or staying asleep. Participants should be generally healthy enough to take part in sleep and mindfulness activities.

Inclusion Criteria

I wake up at least twice a night to urinate.
I have trouble sleeping or insomnia.
I am female.
See 2 more

Exclusion Criteria

Unstable or acute medical condition requiring immediate treatment that would interfere with the study protocol, assessed case-by-case by study physician; stably managed chronic conditions exempt
I have a sleep disorder that is not being treated.
My heart or lung disease makes daily activities difficult.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BBTI, MI, BBTI+MI, or control intervention for 4 weeks

4 weeks
1 visit (in-person) for randomization, followed by at-home interventions

Follow-up

Participants are monitored for sustained effects of the interventions at 3- and 6-months post-treatment

6 months
Assessments at 4 weeks, 3 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • BBTI + MI combined
  • Brief behavioral treatment of insomnia (BBTI)
  • Brief Mindfulness Intervention (MI)
  • Control (sleep information only)

Trial Overview

The study tests if brief behavioral treatment for insomnia (BBTI), brief mindfulness instruction (MI), both together, or just sleep information can help reduce nighttime bathroom trips and improve sleep. Participants are randomly assigned to one of these four groups.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: MIExperimental Treatment1 Intervention
Group II: ControlExperimental Treatment1 Intervention
Group III: BBTI+MIExperimental Treatment1 Intervention
Group IV: BBTIExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials
1,820
Recruited
16,360,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+