About 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®.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female
Age > or =65 years
Nocturia ≥2/night
Poor sleep (Insomnia Severity Index ≥8)
Disqualifiers
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 surgery, current or uncontrolled chronic or recurrent bowel issues, bacterial endocarditis
cardiac or respiratory disease that limits daily function
Untreated, current, severe psychiatric condition (assessed during Visit 1a- medical history)
Post void residual ≥ 200ml- assessed during baseline visit
Trial design
Parallel
Treatments tested in this trial
Brief behavioral treatment of insomnia
BehavioralBBTI: will entail a 45- to 60-minute individual intervention session with instructions regarding sleep education and discussion of homeostatic and circadian mechanisms of human sleep regulation. This education provides the rationale for the 4 main interventions of BBTI: 1. reduce time in bed; 2. get up at the same time every day, regardless of sleep duration; 3. do not go to bed unless sleepy; and 4. do not stay in bed unless asleep
MI
BehavioralParticipants in the MI group will be trained to engage in a brief mindfulness method involving body scan with acceptance language training.
Control
BehavioralThe control condition is intended to emulate the behavioral treatment information generally available to patients.
BBTI+MI
BehavioralParticipants in this arm will receive BBTI as well as MI training.
Treatment groups
Trial outcomes
Primary outcomes
Nocturia
number of nighttime awakenings to void
Other outcomes
Nocturnal polyuria index (NPi)
percentage of 24-hour urine volume excreted at night
Pittsburgh Sleep Quality Index (PSQI)
Self-reported sleep quality questionnaire scored by grouping 19 self-rated questions into seven component scores, summing them into a global score (0 to 21)\> PSQI score \>5 Indicates significant, poor sleep quality and clinical sleep disturbance.
Sponsors and contacts
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University of Pittsburgh
Lead sponsor
National Institute on Aging (NIA)
Collaborator
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