Sleep Disturbance in Patients With End-Stage Renal Disease

NCT02583347 | Unknown

• 1 other identifier: BH-15/36
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep disorders are common in patients who have chronic kidney disease (CKD). Insomnia is reported in up to 50% of patients treated with hemodialysis compared to 12% of a control population. Restless leg syndrome (RLS) and periodic limb movement disorder (PLM) have been described in 30 to 70% of patients with end stage kidney disease (ESKD). Patients with CKD have also been reported to have a very high prevalence of sleep apnoea disorder. Conventional hemodialysis and peritoneal dialysis do not appear to improve sleep disorders in patients with CKD. There is emerging evidence that nocturnal HD can lead to improvements in sleep quality. Transplantation is thought to improve sleep-related disorders in some but not all patients. Project Aims The aims of this project were three-fold:

1. 1.To perform detailed assessment of sleep quality in a cohort of Irish patients with ESRD
2. 2.To assess the feasability and tolerability of unattended home PSG and wrist actigraphy as diagnostic tools in this cohort
3. 3.To assess the impact of a change in RRT modality on sleep quality in Irish patients with ESRD

Conditions

Renal Failure Chronic Requiring Hemodialysis; Sleep Disorders

Outcome Measures

Primary Outcomes (1)

• The prevalence of sleep disorders in a cohort of patients with advanced CKD/ESRD

  from the total sample population of 60

  18 months

Secondary Outcomes (2)

• Change in Subjective Sleep Quality following change of RRT modality

  6 months

• Change in objective sleep quality following change of RRT modality

  6 months

Interventions

Vivia Home Hemodialysis System DEVICE

The cohort of interest is those patients performing nocturnal home hemodialysis using the Vivia Home Hemodialysis System for 8 hours, 5 nights per week

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sixty consecutive patients will be enrolled in the study over a period of 24 months. Patients were prioritized for recruitment if they were active on the transplant waitlist or a change in RRT modality was planned.

You may qualify if:

• \>16 years old,
• competent to independently undertake the informed consent process
• currently on RRT or planned to start RRT in the next three months.

You may not qualify if:

• Patients consuming Benzodiazepine medication
• Patients requiring nasal CPAP for sleep apnoea
• Patients requiring supplemental oxygen
• Patients with dementia, malignancy, or psychiatric disorder

Sponsors & Collaborators

• Beaumont Hospital: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Beaumont Hospital

Dublin, 00, Ireland

RECRUITING

Related Publications (6)

• Roumelioti ME, Brown LK, Unruh ML. The Relationship Between Volume Overload in End-Stage Renal Disease and Obstructive Sleep Apnea. Semin Dial. 2015 Sep-Oct;28(5):508-13. doi: 10.1111/sdi.12389. Epub 2015 May 5.

  PMID: 25940851 BACKGROUND

• Loewen A, Siemens A, Hanly P. Sleep disruption in patients with sleep apnea and end-stage renal disease. J Clin Sleep Med. 2009 Aug 15;5(4):324-9.

  PMID: 19968009 BACKGROUND

• Hanly P. Sleep disorders and home dialysis. Adv Chronic Kidney Dis. 2009 May;16(3):179-88. doi: 10.1053/j.ackd.2009.02.004.

  PMID: 19393968 BACKGROUND

• Mallamaci F, Leonardis D, Tripepi R, Parlongo G, Catalano C, Tripepi G, Castronovo V, Ferini-Strambi L, Zoccali C. Sleep disordered breathing in renal transplant patients. Am J Transplant. 2009 Jun;9(6):1373-81. doi: 10.1111/j.1600-6143.2009.02653.x. Epub 2009 May 20.

  PMID: 19459802 BACKGROUND

• Tang SC, Lam B, Lai AS, Pang CB, Tso WK, Khong PL, Ip MS, Lai KN. Improvement in sleep apnea during nocturnal peritoneal dialysis is associated with reduced airway congestion and better uremic clearance. Clin J Am Soc Nephrol. 2009 Feb;4(2):410-8. doi: 10.2215/CJN.03520708. Epub 2008 Dec 31.

  PMID: 19118118 BACKGROUND

• Hanly PJ, Pierratos A. Improvement of sleep apnea in patients with chronic renal failure who undergo nocturnal hemodialysis. N Engl J Med. 2001 Jan 11;344(2):102-7. doi: 10.1056/NEJM200101113440204.

  PMID: 11150360 BACKGROUND

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Peter J Conlon, MB, MHS

  Beaumont Hospital

  STUDY DIRECTOR

Central Study Contacts

Claire M Kennedy, MB, BMedSci

CONTACT

00353 1 8093000; clairekennedy2@beaumont.ie

Peter J Conlon, MB, MHS

CONTACT

00353 1 8093000; PeterConlon@beaumont.ie

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Fellow

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: October 22, 2015
• Study Start: December 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: August 28, 2017

Record last verified: 2017-08

Locations

IE (1)