NocturiaPhase 3NCT01530451
Clinical Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients
A Phase 3 study testing Desmopressin in people with Nocturia and Obstructive Sleep Apnoea, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nocturia, Obstructive Sleep Apnoea
- What is being tested?
- Desmopressin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteHong Kong
- Study dates
- Mar 2012to Feb 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized, Double-blind Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients
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.
Read the detailed description
Nocturia is one of the commonest urinary symptoms in elderly and in patients with obstructive sleep apnoea (OSA). According to the International Continence Society (ICS) definition, nocturia is defined as "the complaint that the individual has to wake at night one or more times to void" . It implies a continuum beginning from what might be considered normal, to a bothersome state. Bothersome nocturia is a common and age-dependent condition. A prevalence ranging from 48.6% to 77% were reported in the literature. Pathogenesis of nocturia is multi-factorial, and has closely related to OSA. OSA patients generate negative intrathoracic pressure during sleep, this leads to increased venous return and distension of the right atrium. This leads to an increase of hormone secretion, namely Atrial Natriuretic Peptide (ANP). ANP causes increased sodium and water excretion, and inhibits the secretion of antidiuretic hormone. All of the above factors results in an increased nocturnal urine production and nocturia.
Middle-aged men with OSA always present to urology clinic with lower urinary tract symptoms with predominant nocturia. Many a time they were treated as benign prostatic hyperplasia with multiple medications with suboptimal response. The underlying genuine pathology of OSA-related nocturia is overlooked.
Desmopressin is an analogue of antidiuretic hormone, it is the pharmacological therapy of choice for patients with nocturia where night-time polyuria is present.
In this study, the investigators would like 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
- Being tested
- Desmopressin, Placebo
- Keywords
- Nocturia, Obstructive sleep Apnoea, Desmopressin
- Medical subject headings
- Nocturia, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesmopressinDrug
Also called Minirin
120mg OD
PlaceboDrug
one tab OD
| Study group | Role | What they receive |
|---|---|---|
| A: Drug/ Placebo | Experimental | Initial phase on Desmopressin and then cross over to placebo on the second phase Receives: Drug: Desmopressin; Drug: Placebo |
| B: Placebo/ Drug | Experimental | Initial phase on Placebo and then cross over to Desmopressin on the second phase Receives: Drug: Desmopressin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in no. of nocturia
Measured: Week 4 and Week 13
Secondary outcomes (4)
Side effects related to desmopressin
Measured: up to Week 13
Change in quality of Life - NQOL
Measured: Week 4 and Week 13
Change of quality of Sleep - PSQI
Measured: Week 4 and Week 13
Change in lower urinary tract symptoms - OABSS
Measured: Week 4 and Week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: Insufficient funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NocturiaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eddie SY Chan, MD, Chinese University of Hong Kong
- Investigators
- Eddie SY Chan, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530451
- Sponsor's protocol ID
- NOCOSA-001
- Status last verified
- Feb 2015
- First submitted
- 2 Feb 2012
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double-blind Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients
- ClinicalTrials.gov ID
- NCT01530451
- Acronym / sponsor ID
- NOCOSA-001
- Conditions
- Nocturia, Obstructive Sleep Apnoea
- Keywords
- Nocturia, Obstructive sleep Apnoea, Desmopressin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient funding
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 10 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Nocturia is one of the commonest urinary symptoms in elderly and in patients with obstructive sleep apnoea (OSA). According to the International Continence Society (ICS) definition, nocturia is defined as "the complaint that the individual has to wake at night one or more times to void" . It implies a continuum beginning from what might be considered normal, to a bothersome state. Bothersome nocturia is a common and age-dependent condition. A prevalence ranging from 48.6% to 77% were reported in the literature. Pathogenesis of nocturia is multi-factorial, and has closely related to OSA. OSA patients generate negative intrathoracic pressure during sleep, this leads to increased venous return and distension of the right atrium. This leads to an increase of hormone secretion, namely Atrial Natriuretic Peptide (ANP). ANP causes increased sodium and water excretion, and inhibits the secretion of antidiuretic hormone. All of the above factors results in an increased nocturnal urine production and nocturia.
Middle-aged men with OSA always present to urology clinic with lower urinary tract symptoms with predominant nocturia. Many a time they were treated as benign prostatic hyperplasia with multiple medications with suboptimal response. The underlying genuine pathology of OSA-related nocturia is overlooked.
Desmopressin is an analogue of antidiuretic hormone, it is the pharmacological therapy of choice for patients with nocturia where night-time polyuria is present.
In this study, the investigators would like 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Drug/ Placebo | Experimental | Drug: Desmopressin, Drug: PlaceboInitial phase on Desmopressin and then cross over to placebo on the second phase |
| B: Placebo/ Drug | Experimental | Drug: Desmopressin, Drug: PlaceboInitial phase on Placebo and then cross over to Desmopressin on the second phase |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DesmopressinAlso: Minirin120mg OD | Drug | A: Drug/ Placebo, B: Placebo/ Drug |
| Placeboone tab OD | Drug | A: Drug/ Placebo, B: Placebo/ Drug |
Primary outcome
Change in no. of nocturia
Time frame: Week 4 and Week 13
4 secondary outcomes
Side effects related to desmopressin
Time frame: up to Week 13
Change in quality of Life - NQOL
Time frame: Week 4 and Week 13
Change of quality of Sleep - PSQI
Time frame: Week 4 and Week 13
Change in lower urinary tract symptoms - OABSS
Time frame: Week 4 and Week 13
Results and safety
The study was stopped early (reason given: Insufficient funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eddie SY Chan principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Desmopressin in people with Nocturia and Obstructive Sleep Apnoea, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in no. of nocturia (time frame: Week 4 and Week 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2015.