Effect of different compression values of knee-length stockings on reduction of nocturia

JRCT ID: jRCT1072240084

Registered date:10/12/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Nocturia
• Date of first enrollment: 10/12/2024
• Target sample size: 30
• Study type: Interventional

Intervention(s)

1) Screening will be recruited through continence care professional.
2)The order in which to intervene is generated and randomised using Excel.
3) Subjects will wear the following from morning to evening (at least 8 hours) for one week during each intervention period
(1) Intervention period A: Knee-length graduated compreeion stockings for medical use
(2) Intervention period B: Weak pressure Knee-length graduated compreeion stockings
(3) Intervention period C: Regular knee-length socks
4) The post-intervention observation period and washout period will be one week each.
5) One week before the first intervention and one week after the end of all interventions (Week 8) will be the control period.

Outcome(s)

• Primary Outcome: Differences in hours of undisturbed sleep (HUS) from bedtime to first elimination at night due to differences in compression values
• Secondary Outcome: Differences in the number of nocturnal voidings, initial nocturnal voiding volume, nocturnal voiding duration, nocturnal voiding volume, subjective sleep status at night, sleep and activity status (sleep duration, waking time, REM sleep, shallow sleep, deep sleep and sleep score, number of steps taken during the day) and quality of life due to different wearing pressure values

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Subjects must be 40 years of age or older, of either sex, resident in Japan, able to communicate in Japanese, have symptoms of nocturia, and not meet any of the exclusion criteria.

Exclude criteria

If you have been diagnosed with severe heart or kidney failure, poorly controlled diabetes or hypertension, sleep apnea, prostate enlargement, or brain disease such as stroke or Parkinson's disease.
Patients taking calcium channel blockers (dihydropyridine calcium channel blockers) such as Amlodin, Norvasc, Adalat, Atelec, Calblock, or Coniel for treatment of hypertension or angina pectoris.
Those who take sleeping pills or sleep supplements before bedtime.
Patients with severe swelling of the lower extremities that makes it difficult to wear normal socks.
Those who started a new treatment or started taking supplements within 1 month of the survey.
Those who have skin lesions, neuropathy, or poor circulation in the lower extremities.
Those who are prohibited by their physician from wearing knee-length compression stockings.
Patients with malignant diseases
Those who cannot wear knee socks for one week in a row.
Those who have difficulty in checking whether they are wearing elastic knee socks or not.
Those who have to stay awake at night for work.
Those who do not have a smart phone
Those who cannot wear a smart watch during the survey

Related Information

• Primary Sponsor: Mizoguchi Akiko
• Source(s) of Monetary Support: TERUMO LIFE SCIENCE FOUNDATION,Grants-in-Aid for Scientific Research (KAKENHI)