Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness

(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?

What Are the Treatments Tested in This Trial?

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+