Does NIGHT-time dialysis improve quality of LIFE?
Research type
Research Study
Full title
A randomised controlled trial assessing the effectiveness and cost effectiveness of thrice weekly, extended, in-centre nocturnal haemodialysis versus standard care using a mixed methods approach
IRAS ID
280452
Contact name
James Burton
Contact email
Sponsor organisation
University of Leicester
ISRCTN Number
ISRCTN87042063
Duration of Study in the UK
4 years, 11 months, 31 days
Research summary
Research Summary
Kidney dialysis is a lifesaving treatment for around 24,000 patients in the UK. Most patients have a set dialysis appointment time lasting 4 hours, 3 times per week, with travel time in addition. Nocturnal “in-centre” haemodialysis offers patients the opportunity to have their treatment overnight in a hospital or satellite dialysis clinic while they sleep.
Studies suggest that people who have their dialysis overnight may feel better and may be able to live a life which is closer to normal. As overnight dialysis (typically 6-8 hours) is a lengthier treatment, it rids the blood of more waste and excess water, acting more like a patient’s normal kidneys which would be working 24/7. Importantly, it frees up during the day to socialise, work and care for others.
This study asks the question whether 6-months of overnight dialysis, performed 3 times a week in a hospital or satellite centre, improves the quality of life of patients with kidney failure, as compared to those who have shorter dialysis sessions during the day. People who are suitable and consent to take part will be randomised to either daytime dialysis or nocturnal dialysis. Quality of life will be measured after 6-months of treatment using questionnaires that have been specifically designed for kidney patients. We will also collect information on the extra costs of night-time dialysis, to see whether the new treatment is more cost-effective than conventional dialysis care, for the person and the health service. Finally, we will evaluate the experiences of patients who are enrolled in the study to identify barriers to how the treatment would be rolled out across the NHS, if we were to find that it does benefit patients.
Summary of Results
Study title: A randomised controlled trial assessing the effectiveness and cost effectiveness of thrice weekly, extended, in-centre nocturnal haemodialysis versus standard care using a mixed methods approach: NightLife
Who carried out the research? The trial was sponsored by the University of Leicester. The research was led by Chief Investigator Professor James Burton. The trial was funded by a grant from the National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) Programme (Funder reference: NIHR127440). Ethical approval was reviewed and granted by the West Midlands – Coventry & Warwickshire Research Ethics Committee (REC reference: 20/WM/0275).
What public involvement was there in the study (how many people, what their relevant lived experience was, and what they did)? Patients and the public were involved in the concept, scope, and design of this study from the very outset. Through consultation with the Leicester Kidney Patient and Public Involvement (PPI) Group, which comprises around 80 kidney patients, relatives, and carers, in-centre nocturnal dialysis was highlighted as a top research priority. A specific haemodialysis PPI panel met four times over two years to shape the trial design, including choosing the outcome measures and suggesting health economic evaluations into the treatment's impact on carers and family members.
Expert patient Madeleine Warren was a study co-applicant and served as a lay representative on the Trial Steering Committee (TSC) alongside an additional independent expert patient to review trial data and help report the findings. A study-specific Patient and Public Involvement and Experience (PPIE) panel was also established across multiple dialysis units to act as a main channel of communication, inform research focuses, and clear barriers to delivery. Additionally, an independent Data Monitoring Committee (DMC) monitored participant safety data throughout the trial.Where and when did the study take place? The NightLife trial took place across multiple hospital and satellite dialysis units in the UK. These included Ysbyty Gwynedd Renal Unit, New Victoria Hospital Dialysis Unit, Dulwich Satellite Unit, Tameside Renal Dialysis Unit, Octogan Satellite Unit, Daisy Hill Renal Unit, Stockton Dialysis Unit, and several University Hospitals of Leicester units (Leicester General Hospital, Kettering, Loughborough, and Hamilton renal units). The final statistical report was completed on 19th February 2026, following completion of data collection on 2nd September 2025.
Why was the research needed? Regular daytime haemodialysis is a life-saving treatment for patients with kidney failure, but it places extensive physiological, psychological, and sociological burdens on patients. Because patients must spend roughly 4 hours on a machine three times a week during the day, they effectively lose three days of every week, leaving many unable to maintain employment or live a normal lifestyle. Nightime haemodialysis offers the chance to dialyse overnight for a longer 6-to-8-hour period while asleep. Overnight sessions remove body waste more thoroughly and fluid more slowly, which replicates normal kidney function better and helps heart stability. This trial aimed to find out if extended nighttime dialysis improves quality of life and adds value for money for the NHS when compared to current daytime dialysis.
What were the main questions asked?
The main aims of the trial were:
1. To measure the effect of extended hours nighttime dialysis compared with daytime dialysis on a measure of health-related quality of life called the Kidney Disease Quality of Life (KDQoL-36) questionnaire over a 6-month period.
2. To evaluate a number of other patient-reported outcomes at 1, 3, and 6 months, including general well-being (EQ-5D-5L), levels of fatigue (SONG-HD), sleep quality (PSQI), time to recovery after dialysis (TTR), and cognitive health (MoCA).
3. To monitor safety outcomes, including Serious Adverse Events (SAEs) and changes in residual kidney function.
4. To compare the value for money between daytime and nighttime dialysis by determining the cost for each extra year of healthy life it gives a patient.Who participated in the study? A total of 100 adult patients already having daytime dialysis for at least 3 months were recruited: 57 received extended nighttime dialysis and 43 continued with daytime dialysis. The recruited 72 males and 28 females, with an overall average age of 53.5 years. In terms of ethnic demographics, 60 participants were White British, 28 were Black or Black British, 9 were Asian or Asian British, and 3 belonged to other ethnic groups. A total of 81 participants (47 nighttime, 34 daytime) fully completed the trial follow-up period of 6 months.
What treatments or interventions did the participants take/receive? Participants were assigned to one of two dialysis paths for a 6-month period:
● Nighttime Dialysis Group: Received 6 to 8 hours of in-centre dialysis delivered overnight, 3 times per week. On average, participants in this group attended 6.61 hours per session.
● Daytime Dialysis Group (Standard Care): Received 3.5 to 5 hours of daytime in-centre haemodialysis, 3 times per week. On average, participants in this group attended 4.07 hours per session.To maximize adaptation success, "starter packs" containing items like blindfolds and earplugs were used to support participants sleeping in the units.
What medical problems did the participants have? The safety population evaluated 89 participants who commenced study activities after they were recruited. A total of 52 Serious Adverse Events (SAEs) were reported among 24 unique participants. A slightly higher proportion of individuals experienced an SAE in the nocturnal dialysis arm (29.2%) compared to the daytime arm (24.4%).
The majority of reported events (96.1%) were deemed "not related" to the study intervention, reflecting the complex baseline health of dialysis cohorts. Only 2 vascular access complications (clotted access grafts) in the nighttime group were categorized as "possibly related" to the intervention. Two fatal events occurred during the timeline, both within the daytime standard care group, and neither was related to the study.What were the results of the study? Because the trial was stopped early, the final participant dataset was smaller than expected, resulting in an underpowered analysis. The primary quality of life metrics showed a slight absolute numerical trend favouring the nighttime route, with an adjusted mean difference improvement of 3.00 points on the KDQoL total score over 6 months. However, this shift was not statistically significant (p = 0.702), meaning the difference could be due to chance.
Similarly, secondary analyses showed no significant differences between groups across time points for general health utility, sleep quality, fatigue scores, or the time needed to physically recover after a session. A small increase in cognitive test performance (MoCA) was observed at 6 months for nighttime participants (adjusted difference of 1.10), though its absolute clinical significance remains limited due to the small trial sample size.How has this study helped patients and researchers? Despite being underpowered due to early closure, the trial provided vital evidence confirming that extended overnight, in-centre dialysis is entirely safe and does not raise clinical risk or serious complication rates compared to standard care. It proved that overnight clinical shifts are highly viable, generating an essential framework for medical teams and healthcare commissioners working to implement more flexible, independent scheduling options for dialysis patients.
Where can I learn more about this study? You can view the trial's registry parameters and milestone timelines on the public ISRCTN registry database using the identifying code ISRCTN11722317.
Thank you to trial participants We extend our deepest gratitude to all the participants, families, and carers who supported the NightLife study. Adjusting your medical routine, tracking your experiences, and filling out regular questionnaires has provided our research team with invaluable data that will directly help improve the flexibility and responsiveness of long-term kidney care.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
20/WM/0275
Date of REC Opinion
10 Dec 2020
REC opinion
Further Information Favourable Opinion