Clinical Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients

NCT01530451 | Terminated Phase 3

• 1 other identifier: NOCOSA-001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the efficacy of desmopressin on symptoms of nocturia in patients with Obstructive Sleep Apnoea (OSA). The improvement of sleep quality and the quality of life will be measured.

Conditions

Nocturia; Obstructive Sleep Apnoea

Keywords

Nocturia; Obstructive sleep Apnoea; Desmopressin

Outcome Measures

Primary Outcomes (1)

• Change in no. of nocturia

  Week 4 and Week 13

Secondary Outcomes (4)

• Side effects related to desmopressin

  up to Week 13

• Change in quality of Life - NQOL

  Week 4 and Week 13

• Change of quality of Sleep - PSQI

  Week 4 and Week 13

• Change in lower urinary tract symptoms - OABSS

  Week 4 and Week 13

Study Arms (2)

A: Drug/ Placebo

EXPERIMENTAL

Initial phase on Desmopressin and then cross over to placebo on the second phase

Drug: Desmopressin; Drug: Placebo

B: Placebo/ Drug

EXPERIMENTAL

Initial phase on Placebo and then cross over to Desmopressin on the second phase

Drug: Desmopressin; Drug: Placebo

Interventions

Desmopressin DRUG

120mg OD

Also known as: Minirin

A: Drug/ Placebo; B: Placebo/ Drug

Placebo DRUG

one tab OD

A: Drug/ Placebo; B: Placebo/ Drug

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male or female patient (aged\</=65 years old)
• Obstructive sleep apnoea diagnosed by sleep study
• Stable treatment on obstructive sleep apnoea and / or LUTS
• Nocturia on average more than once per night
• Having the ability to communicate and comply with the requirements of the study

You may not qualify if:

• Presence of urethral strictures and neurogenic bladder dysfunction
• Clinical evidence of bladder stones, bladder tumor or an active urinary tract infection
• History of prostate cancer or prostate specific antigen (PSA) level \> 10ng/ml or suspicious of prostate cancer on digital rectal examination (DRE), unless a transrectal biopsy of prostate has been performed and the presence of prostate cancer has been excluded.
• Patient on intermittent self-catheterisation
• Recent start or change of treatment on obstructive sleep apnoea and / or nocturia
• Uncontrolled medical problems: e.g. Diabetes Mellitus or Diabetes insipidus
• Hyponatraemia
• Pregnancy

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Nocturia; Sleep Apnea, Obstructive

Interventions

Deamino Arginine Vasopressin

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Eddie SY Chan

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Associate Professor

Study Record Dates

• First Submitted: February 2, 2012
• First Posted: February 10, 2012
• Study Start: March 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

HK (1)